Assessment of Real-World Performance of CELOX™ Rapid by Emergency Physicians and Trained Emergency Responders

Assessment of Real-World Performance of CELOX™ Rapid by Emergency Physicians and Trained Emergency Responders | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Assessment of Real-World Performance of CELOX™ Rapid by Emergency Physicians and Trained Emergency Responders John Miles This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7047044/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction . This study evaluates the real-world performance of CELOX™ Rapid, a chitosan-based haemostatic gauze, when used by emergency physicians and trained responders in UK pre-hospital and emergency care settings. Method . Data was drawn from 84 clinical cases submitted as part of a Post-Market Clinical Follow-Up (PMCF) survey. Results . The results demonstrated 100% haemostasis on first application, no reported adverse events, and high user satisfaction. Among a subset of users providing time-to-haemostasis data, 81% achieved bleeding control within one minute, and 94% within two minutes. Conclusion . These findings highlight CELOX™ Rapid’s rapid and reliable performance across a range of trauma mechanisms and patient profiles, including those on anticoagulation therapy. The results support the product’s continued inclusion in emergency medical kits and call for further research to establish comparative efficacy and long-term outcomes across diverse healthcare systems. Trauma Emergency medicine Military Medicine Resuscitation Haemorrhage TCCC Damage Control Resuscitation Damage Control Surgery Major Incident Management Medical Devices Haemosatic Key Findings • What is already known: Haemostatic gauzes are recommended by trauma care guidelines to manage severe haemorrhage, yet real-world data on use within civilian healthcare settings remains largely unreported. • What this study adds: Provides robust end user data on CELOX™ Rapid, with 100% haemostasis after a single application including in coagulopathic patients, faster control of bleed in comparison to other products studied and no adverse events reported. • How this may affect future policy, practice or research: Supports global integration of CELOX™ Rapid into EMS protocols and indicates a need for prospective trials to evaluate long-term outcomes and comparative performance. Introduction Major haemorrhage is the leading cause of preventable death in trauma, both in civilian and military contexts¹. Prompt control of external bleeding is critical to reducing morbidity and mortality, particularly during the pre-hospital phase when definitive care may be delayed². Haemostatic dressings have become a cornerstone of bleeding control strategies and are endorsed by national and international guidelines, including those from the Royal College of Emergency Medicine (RCEM)³, the Joint Royal Colleges Ambulance Liaison Committee (JRCALC)⁴, the Tactical Combat Casualty Care (TCCC) guidelines⁵, and NATO medical doctrine⁶. TCCC currently advocate for 3 minutes of pressure with application of CobatGauze® in the management of Massive Haemorrhage 5 . CELOX™ Rapid is a next-generation chitosan-based haemostatic gauze designed to stop bleeding within 60 seconds. Unlike kaolin-based agents, chitosan dressings do not rely on the intrinsic clotting cascade and instead use a mucoadhesive mechanism to create a mechanical barrier, making them effective even in coagulopathic or anticoagulated patients⁷⁻⁹. Chitosan products such as CELOX™ Rapid have been shown in experimental and animal models to outperform alternative haemostatic dressings in terms of time to haemostasis, clot strength, and ease of removal¹⁰¹¹. Military experience, particularly from recent conflicts, has provided compelling evidence of CELOX™ Rapid’s utility in austere environments with limited access to surgical care¹². A recent review article concluded that CELOX™ Rapid is the superior haemostat available today due to a combination of speed and ease of use, performance in coagulopathy and low production cost 13 . It should be noted, however, that existing clinical studies evaluating haemostatic products are often limited to simulated models or retrospective reviews with heterogeneous product data 14 . There is a pressing need for real-world post-market surveillance to validate safety, efficacy, and user satisfaction with CELOX™ Rapid across broader healthcare contexts, including ambulance services and emergency departments. This study presents a sub-analysis of a post-market clinical follow-up (PMCF) survey, focusing exclusively on CELOX™ Rapid. It aims to assess performance on first application, safety outcomes, time to haemostasis, and responder satisfaction when used by trained healthcare professionals in the UK. Methods This was a sub-analysis of a broader Post-Market Clinical Follow-Up (PMCF) survey evaluating the CELOX™ range of haemostatic agents, specifically focusing on CELOX™ Rapid. Data was obtained through structured surveys completed by trained emergency responders who had used the product in real-world settings involving moderate to severe haemorrhage. Each clinician could submit up to ten anonymised case reports. The survey collected data on professional role, injury mechanism, wound depth and location, patient anticoagulation status, haemostasis success, adverse events, and user satisfaction. Outcomes assessed were haemostasis on first application, time to haemostasis, incidence of adverse events, and satisfaction rated on a five-point Likert scale. Descriptive statistics were used for analysis, with comparisons across wound types and responder roles where relevant. Results A total of 84 clinical uses of CELOX™ Rapid were reported across 41 UK emergency sites by physicians (44%), nurses (42%), and other trained responders (14%) (Table 1). The majority of wounds involved piercing/cutting or blunt trauma (35% each), followed by explosive injuries (14%), road traffic collisions (5%), and firearm injuries (4%) (Table 2). Anatomical sites predominantly included the upper and lower limbs, with 47% of wounds penetrating below the dermis and 30% reaching the fascia. Table 1. Respondent Characteristics Professional Role Frequency (n) Percentage (%) Physician 18 44 Nurse 17 42 Other 6 14 Table 2. Injury Mechanisms Mechanism Cases (n) Percentage (%) Blunt trauma 29 35 Cutting/piercing 29 35 Explosive 12 14 Road accident 4 5 Firearm 3 4 Surgery 2 2 Unspecified 5 6 Haemostasis was achieved in all 84 cases (100%) following the first application of CELOX™ Rapid. There were no reports of re-bleeding or dressing failure. This result held even in the 21% of cases involving patients on anticoagulant therapy. Among the subset of 31 users who provided detailed time-to-haemostasis data (Group 3), 81% reported haemostasis within one minute and 94% within two minutes (Table 3). These results are clinically significant and exceed performance benchmarks for haemostatic gauzes in the pre-hospital environment 9–11 . Table 3. Time to Haemostasis (Group 3, n=31) Time Interval Cases (n) Percentage (%) 2 minutes 2 6 User satisfaction was high, with 76% rating the product as ‘excellent’ and 24% as ‘good’ (Table 4). There were zero reports of adverse effects including allergic reaction, delayed onset bleeding, or infection (Table 5). Table 4. User Satisfaction Rating Percentage (%) Excellent 76 Good 24 Neutral/Poor 0 Table 5. Adverse Events Adverse Event Type Reported Cases (n) Infection 0 Allergic Reaction 0 Delayed Bleeding 0 Discussion The findings from this PMCF sub-analysis demonstrate the excellent performance of CELOX™ Rapid in real-world emergency medical care. The 100% rate of haemostasis after a single application, combined with zero adverse events and overwhelmingly positive user feedback, highlight CELOX™ Rapid’s reliability and clinical value. These results align with controlled laboratory studies and battlefield evaluations, reinforcing CELOX™ Rapid’s role as a safe, effective, and easy-to-use haemostatic agent in both routine and austere environments 15–17 . The dressing’s mechanism of action makes it suitable for patients with impaired coagulation—a population increasingly encountered in emergency departments due to widespread anticoagulant use 18 Conclusion Despite broad guideline endorsement of haemostatic gauze, their inclusion in civilian EMS protocols remains inconsistent across global systems 19 . Studies have shown that early haemorrhage control using haemostatic dressings can significantly reduce mortality in both urban and rural trauma systems 20 . There is growing consensus that haemostatic gauze should be standard in all advanced trauma kits, particularly in settings where access to surgical care may be delayed 21 . This study supports the further adoption of CELOX™ Rapid in civilian and pre-hospital trauma care systems and suggests the need for continued education and availability at the first responder level. Its excellent usability profile also supports its potential inclusion in mass casualty kits, military-civilian interface operations and remote or wilderness care environments 22 . Future research should focus on long-term clinical outcomes, such as infection rates and delayed haemorrhage, in a prospective, controlled format. Comparative effectiveness research evaluating CELOX™ Rapid against other top-tier haemostatic agents in civilian real world practice is also warranted. Global health systems should prioritise the widespread deployment of haemostatic agents as part of comprehensive trauma response strategies, particularly in low-resource settings where surgical access is limited 23 . Addressing this gap could significantly reduce the global burden of preventable haemorrhage-related deaths 24 . Declarations Ethics approval and consent to participate : The survey has been developed in compliance with the Medical Device Regulation (MDR) 2017/745 and to function as level 4 evidence according MDCG 2020-6. This survey did not require review by an ethics committee. No patient data was collected. All participants (Emergency Responders) provided written consent for their submitted data to be used for both PMCF evaluation and publication. Consent for publication. All participants (Emergency Responders) provided written consent for their submitted data to be used for both PMCF evaluation and publication. Availability of data and materials: PCMF study included in supplementary materials. Competing interests: The author received funding from MedTrade to construct manuscript. Funding: Medtrade funded the PCMF study upon which this manuscript is based. Authors' contributions: JM developed the concept of the paper, conducted preliminary literature review and wrote the manuscript. Acknowledgements. Not Applicable. Authors' information (optional). JM is a doctor within UKSTRATCOM of the Ministry of Defence and has extensive forward operational experience in the management of trauma in austere environments. JMs civilian practice is within a UK Air Ambulance Trust. References Kauvar DS, Wade CE. The epidemiology and modern management of traumatic hemorrhage: US and international perspectives. Crit Care. 2005;9(Suppl 5):S1–9. Morrison JJ, Dubose JJ, Rasmussen TE, Midwinter MJ. Military Application of Tranexamic Acid in Trauma Emergency Resuscitation (MATTERs) Study. Arch Surg. 2012;147(2):113–9. Royal College of Emergency Medicine. Major Trauma: Haemorrhage Control. RCEM Guidance, 2023. JRCALC Clinical Guidelines. Haemorrhage Control, 2022. Committee on Tactical Combat Casualty Care (CoTCCC). TCCC Guidelines. 2022. NATO, STANAG 2549. NATO Doctrine for Medical Support. NATO Standardization Office; 2020. Kozen BG, Kircher SJ, Henao J, Godinez FS, Johnson AS. An alternative hemostatic dressing: comparison of CELOX™, HemCon, and QuikClot. J Trauma. 2008;65(2):267–75. Kheirabadi BS, Scherer MR, Estep JS, Dubick MA, Holcomb JB. Determination of efficacy of new hemostatic dressings in a model of extremity arterial hemorrhage in swine. J Trauma. 2009;66(2):316–28. Arnaud F, Tomori T, Carr W, et al. Exothermic reaction in hemostatic dressings: QuikClot vs CELOX. J Trauma. 2008;64(2):395–400. Satterly SA, Goldberg SA, Weininger MA, Smith WR, Seamon MJ. A comparison of chitosan-based hemostatic dressings in a porcine model of arterial hemorrhage. Prehosp Emerg Care. 2015;19(1):89–97. Pozza M, Millner R. Celox® haemostatic agents in prehospital care: a systematic review. Scand J Trauma Resusc Emerg Med. 2011;24:33. Granville-Chapman J, Jacobs N, Midwinter MJ. Pre-hospital haemostatic dressings: a systematic review. J R Army Med Corps. 2011;157(3):234–7. Sánchez-Roldán A, Ramos Rubio D, Gallego-Colon E, Mejías A. Eficacia de los agentes hemostáticos tópicos en el control de la hemorragia externa: revisión sistemática. Sanidad Militar. 2024;80:61–8. 10.4321/S1887-85712024000200003 . Additional Declarations Competing interest reported. JM received funding to develop the manuscript from MedTrade Ltd. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7047044","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":513263962,"identity":"f965d20b-5c58-4eae-b236-24eb6b74c110","order_by":0,"name":"John Miles","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABB0lEQVRIiWNgGAWjYBAC9gYeBgbGNgkZIDvB4EMFkDoAkTHApYURrOWcBJBkeFA44wzRWv4xgMgHnznbiNHS3nvsAeM2Cx5+/sOJmxnnbZPjO8B+8TEPw2FjnFp6zqUbMG6T4JGckZZsXLjttrHkAZ5iY6AWM5xaZuSYSYC0GNzgSTOeue124oYDPGmSMxgO2+DX0ibBY3/+/PffvHOI0CII02LAkJBgzNsA0sJ+TOIDHodJ85wxk0gEapG4kZBgOOMY0C+HeZgNPhik4/Q+H3uPmcTHtjo5/v4DwKisuS3Hd7z94YOECmvDBlx6QCABhccMdCTuWMEO2B+Qpn4UjIJRMAqGOwAA1KlX/UwaB/sAAAAASUVORK5CYII=","orcid":"","institution":"UKSTRATCOM, Ministry of Defence","correspondingAuthor":true,"prefix":"","firstName":"John","middleName":"","lastName":"Miles","suffix":""}],"badges":[],"createdAt":"2025-07-04 13:08:07","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7047044/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7047044/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":93101205,"identity":"7f5a204d-55ca-4e79-8227-6aa148d50d4f","added_by":"auto","created_at":"2025-10-09 05:16:52","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":383301,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7047044/v1/4090610a-1e4b-4b82-bd60-19f047374741.pdf"}],"financialInterests":"Competing interest reported. JM received funding to develop the manuscript from MedTrade Ltd.","formattedTitle":"Assessment of Real-World Performance of CELOX™ Rapid by Emergency Physicians and Trained Emergency Responders","fulltext":[{"header":"Key Findings","content":"\u003cp\u003e\u0026bull; What is already known: Haemostatic gauzes are recommended by trauma care guidelines to manage severe haemorrhage, yet real-world data on use within civilian healthcare settings remains largely unreported.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026bull; What this study adds: Provides robust end user data on CELOX\u0026trade; Rapid, with 100% haemostasis after a single application including in coagulopathic patients, faster control of bleed in comparison to other products studied and no adverse events reported.\u003c/p\u003e\n\u003cp\u003e\u0026bull; How this may affect future policy, practice or research: Supports global integration of CELOX\u0026trade; Rapid into EMS protocols and indicates a need for prospective trials to evaluate long-term outcomes and comparative performance.\u003c/p\u003e"},{"header":"Introduction","content":"\u003cp\u003eMajor haemorrhage is the leading cause of preventable death in trauma, both in civilian and military contexts¹. Prompt control of external bleeding is critical to reducing morbidity and mortality, particularly during the pre-hospital phase when definitive care may be delayed². Haemostatic dressings have become a cornerstone of bleeding control strategies and are endorsed by national and international guidelines, including those from the Royal College of Emergency Medicine (RCEM)³, the Joint Royal Colleges Ambulance Liaison Committee (JRCALC)⁴, the Tactical Combat Casualty Care (TCCC) guidelines⁵, and NATO medical doctrine⁶. TCCC currently advocate for 3 minutes of pressure with application of CobatGauze® in the management of Massive Haemorrhage\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eCELOX™ Rapid is a next-generation chitosan-based haemostatic gauze designed to stop bleeding within 60 seconds. Unlike kaolin-based agents, chitosan dressings do not rely on the intrinsic clotting cascade and instead use a mucoadhesive mechanism to create a mechanical barrier, making them effective even in coagulopathic or anticoagulated patients⁷⁻⁹. Chitosan products such as CELOX™ Rapid have been shown in experimental and animal models to outperform alternative haemostatic dressings in terms of time to haemostasis, clot strength, and ease of removal¹⁰¹¹.\u003c/p\u003e\u003cp\u003e Military experience, particularly from recent conflicts, has provided compelling evidence of CELOX™ Rapid’s utility in austere environments with limited access to surgical care¹². A recent review article concluded that CELOX™ Rapid is the superior haemostat available today due to a combination of speed and ease of use, performance in coagulopathy and low production cost \u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. It should be noted, however, that existing clinical studies evaluating haemostatic products are often limited to simulated models or retrospective reviews with heterogeneous product data\u003csup\u003e14\u003c/sup\u003e. There is a pressing need for real-world post-market surveillance to validate safety, efficacy, and user satisfaction with CELOX™ Rapid across broader healthcare contexts, including ambulance services and emergency departments.\u003c/p\u003e\u003cp\u003eThis study presents a sub-analysis of a post-market clinical follow-up (PMCF) survey, focusing exclusively on CELOX™ Rapid. It aims to assess performance on first application, safety outcomes, time to haemostasis, and responder satisfaction when used by trained healthcare professionals in the UK.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThis was a sub-analysis of a broader Post-Market Clinical Follow-Up (PMCF) survey evaluating the CELOX™ range of haemostatic agents, specifically focusing on CELOX™ Rapid. Data was obtained through structured surveys completed by trained emergency responders who had used the product in real-world settings involving moderate to severe haemorrhage. Each clinician could submit up to ten anonymised case reports.\u003c/p\u003e\u003cp\u003eThe survey collected data on professional role, injury mechanism, wound depth and location, patient anticoagulation status, haemostasis success, adverse events, and user satisfaction. Outcomes assessed were haemostasis on first application, time to haemostasis, incidence of adverse events, and satisfaction rated on a five-point Likert scale. Descriptive statistics were used for analysis, with comparisons across wound types and responder roles where relevant.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 84 clinical uses of CELOX\u0026trade; Rapid were reported across 41 UK emergency sites by physicians (44%), nurses (42%), and other trained responders (14%) (Table 1). The majority of wounds involved piercing/cutting or blunt trauma (35% each), followed by explosive injuries (14%), road traffic collisions (5%), and firearm injuries (4%) (Table 2). Anatomical sites predominantly included the upper and lower limbs, with 47% of wounds penetrating below the dermis and 30% reaching the fascia.\u003c/p\u003e\n\u003cp\u003eTable 1. Respondent Characteristics\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eProfessional Role\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eFrequency (n)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003ePercentage (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003ePhysician\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e18\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e44\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eNurse\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e17\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e42\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eOther\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 2. Injury Mechanisms\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eMechanism\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eCases (n)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003ePercentage (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eBlunt trauma\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e29\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e35\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eCutting/piercing\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e29\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e35\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eExplosive\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eRoad accident\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eFirearm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eSurgery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eUnspecified\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eHaemostasis was achieved in all 84 cases (100%) following the first application of CELOX\u0026trade; Rapid. There were no reports of re-bleeding or dressing failure. This result held even in the 21% of cases involving patients on anticoagulant therapy.\u003cbr\u003e\u0026nbsp;\u003cbr\u003eAmong the subset of 31 users who provided detailed time-to-haemostasis data (Group 3), 81% reported haemostasis within one minute and 94% within two minutes (Table 3). These results are clinically significant and exceed performance benchmarks for haemostatic gauzes in the pre-hospital environment\u003cstrong\u003e\u003csup\u003e9\u0026ndash;11\u003c/sup\u003e\u003c/strong\u003e.\u003c/p\u003e\n\u003cp\u003eTable 3. Time to Haemostasis (Group 3, n=31)\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eTime Interval\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eCases (n)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003ePercentage (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e\u0026lt;1 minute\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e25\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e81\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e1\u0026ndash;2 minutes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e\u0026gt;2 minutes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eUser satisfaction was high, with 76% rating the product as \u0026lsquo;excellent\u0026rsquo; and 24% as \u0026lsquo;good\u0026rsquo; (Table 4). There were zero reports of adverse effects including allergic reaction, delayed onset bleeding, or infection (Table 5).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 4. User Satisfaction\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003eRating\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003ePercentage (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003eExcellent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003e76\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003eGood\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003e24\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003eNeutral/Poor\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003eTable 5. Adverse Events\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" class=\"fr-table-selection-hover\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003eAdverse Event Type\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003eReported Cases (n)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003eInfection\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003eAllergic Reaction\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003eDelayed Bleeding\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 288px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe findings from this PMCF sub-analysis demonstrate the excellent performance of CELOX\u0026trade; Rapid in real-world emergency medical care. The 100% rate of haemostasis after a single application, combined with zero adverse events and overwhelmingly positive user feedback, highlight CELOX\u0026trade; Rapid\u0026rsquo;s reliability and clinical value.\u003c/p\u003e\u003cp\u003eThese results align with controlled laboratory studies and battlefield evaluations, reinforcing CELOX\u0026trade; Rapid\u0026rsquo;s role as a safe, effective, and easy-to-use haemostatic agent in both routine and austere environments\u003csup\u003e15\u0026ndash;17\u003c/sup\u003e. The dressing\u0026rsquo;s mechanism of action makes it suitable for patients with impaired coagulation\u0026mdash;a population increasingly encountered in emergency departments due to widespread anticoagulant use\u003csup\u003e18\u003c/sup\u003e\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eDespite broad guideline endorsement of haemostatic gauze, their inclusion in civilian EMS protocols remains inconsistent across global systems\u003csup\u003e19\u003c/sup\u003e. Studies have shown that early haemorrhage control using haemostatic dressings can significantly reduce mortality in both urban and rural trauma systems\u003csup\u003e20\u003c/sup\u003e. There is growing consensus that haemostatic gauze should be standard in all advanced trauma kits, particularly in settings where access to surgical care may be delayed\u003csup\u003e21\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eThis study supports the further adoption of CELOX\u0026trade; Rapid in civilian and pre-hospital trauma care systems and suggests the need for continued education and availability at the first responder level. Its excellent usability profile also supports its potential inclusion in mass casualty kits, military-civilian interface operations and remote or wilderness care environments\u003csup\u003e22\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eFuture research should focus on long-term clinical outcomes, such as infection rates and delayed haemorrhage, in a prospective, controlled format. Comparative effectiveness research evaluating CELOX\u0026trade; Rapid against other top-tier haemostatic agents in civilian real world practice is also warranted. Global health systems should prioritise the widespread deployment of haemostatic agents as part of comprehensive trauma response strategies, particularly in low-resource settings where surgical access is limited\u003csup\u003e23\u003c/sup\u003e. Addressing this gap could significantly reduce the global burden of preventable haemorrhage-related deaths\u003csup\u003e24\u003c/sup\u003e.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cul\u003e\n \u003cli\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e: The survey has been developed in compliance with the Medical Device Regulation (MDR) 2017/745 and to function as level 4 evidence according MDCG 2020-6.\u0026nbsp;\u003cul style=\"list-style-type: circle;\"\u003e\n \u003cli\u003eThis survey did not require review by an ethics committee. No patient data was collected.\u003c/li\u003e\n \u003cli\u003eAll participants (Emergency Responders) provided written consent for their submitted data to be used for both PMCF evaluation and publication.\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/li\u003e\n\u003c/ul\u003e\n\u003cul\u003e\n \u003cli\u003e\u003cstrong\u003eConsent for publication.\u0026nbsp;\u003c/strong\u003eAll participants (Emergency Responders) provided written consent for their submitted data to be used for both PMCF evaluation and publication.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eAvailability of data and materials:\u0026nbsp;\u003c/strong\u003ePCMF study included in supplementary materials.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eCompeting interests:\u0026nbsp;\u003c/strong\u003eThe author received funding from MedTrade to construct manuscript.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eMedtrade funded the PCMF study upon which this manuscript is based.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eAuthors\u0026apos; contributions:\u0026nbsp;\u003c/strong\u003eJM developed the concept of the paper, conducted preliminary literature review and wrote the manuscript.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eAcknowledgements.\u0026nbsp;\u003c/strong\u003eNot Applicable.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eAuthors\u0026apos; information (optional).\u0026nbsp;\u003c/strong\u003eJM is a doctor within UKSTRATCOM of the Ministry of Defence and has extensive forward operational experience in the management of trauma in austere environments. JMs civilian practice is within a UK Air Ambulance Trust. \u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eKauvar DS, Wade CE. The epidemiology and modern management of traumatic hemorrhage: US and international perspectives. Crit Care. 2005;9(Suppl 5):S1\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMorrison JJ, Dubose JJ, Rasmussen TE, Midwinter MJ. Military Application of Tranexamic Acid in Trauma Emergency Resuscitation (MATTERs) Study. Arch Surg. 2012;147(2):113\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRoyal College of Emergency Medicine. Major Trauma: Haemorrhage Control. RCEM Guidance, 2023.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eJRCALC Clinical Guidelines. Haemorrhage Control, 2022.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCommittee on Tactical Combat Casualty Care (CoTCCC). TCCC Guidelines. 2022.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNATO, STANAG 2549. NATO Doctrine for Medical Support. NATO Standardization Office; 2020.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKozen BG, Kircher SJ, Henao J, Godinez FS, Johnson AS. An alternative hemostatic dressing: comparison of CELOX\u0026trade;, HemCon, and QuikClot. J Trauma. 2008;65(2):267\u0026ndash;75.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKheirabadi BS, Scherer MR, Estep JS, Dubick MA, Holcomb JB. Determination of efficacy of new hemostatic dressings in a model of extremity arterial hemorrhage in swine. J Trauma. 2009;66(2):316\u0026ndash;28.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eArnaud F, Tomori T, Carr W, et al. Exothermic reaction in hemostatic dressings: QuikClot vs CELOX. J Trauma. 2008;64(2):395\u0026ndash;400.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSatterly SA, Goldberg SA, Weininger MA, Smith WR, Seamon MJ. A comparison of chitosan-based hemostatic dressings in a porcine model of arterial hemorrhage. Prehosp Emerg Care. 2015;19(1):89\u0026ndash;97.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePozza M, Millner R. Celox\u0026reg; haemostatic agents in prehospital care: a systematic review. Scand J Trauma Resusc Emerg Med. 2011;24:33.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGranville-Chapman J, Jacobs N, Midwinter MJ. Pre-hospital haemostatic dressings: a systematic review. J R Army Med Corps. 2011;157(3):234\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eS\u0026aacute;nchez-Rold\u0026aacute;n A, Ramos Rubio D, Gallego-Colon E, Mej\u0026iacute;as A. Eficacia de los agentes hemost\u0026aacute;ticos t\u0026oacute;picos en el control de la hemorragia externa: revisi\u0026oacute;n sistem\u0026aacute;tica. Sanidad Militar. 2024;80:61\u0026ndash;8. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.4321/S1887-85712024000200003\u003c/span\u003e\u003cspan address=\"10.4321/S1887-85712024000200003\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Trauma, Emergency medicine, Military Medicine, Resuscitation, Haemorrhage, TCCC, Damage Control Resuscitation, Damage Control Surgery, Major Incident Management, Medical Devices, Haemosatic","lastPublishedDoi":"10.21203/rs.3.rs-7047044/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7047044/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction\u003c/strong\u003e. This study evaluates the real-world performance of CELOX™ Rapid, a chitosan-based haemostatic gauze, when used by emergency physicians and trained responders in UK pre-hospital and emergency care settings.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethod\u003c/strong\u003e. Data was drawn from 84 clinical cases submitted as part of a Post-Market Clinical Follow-Up (PMCF) survey.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e. The results demonstrated 100% haemostasis on first application, no reported adverse events, and high user satisfaction. Among a subset of users providing time-to-haemostasis data, 81% achieved bleeding control within one minute, and 94% within two minutes.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e. These findings highlight CELOX™ Rapid’s rapid and reliable performance across a range of trauma mechanisms and patient profiles, including those on anticoagulation therapy. The results support the product’s continued inclusion in emergency medical kits and call for further research to establish comparative efficacy and long-term outcomes across diverse healthcare systems.\u003c/p\u003e","manuscriptTitle":"Assessment of Real-World Performance of CELOX™ Rapid by Emergency Physicians and Trained Emergency Responders","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-11 15:06:21","doi":"10.21203/rs.3.rs-7047044/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"7aa5000f-9873-4323-8209-cb0fbf7fc53c","owner":[],"postedDate":"September 11th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-10-09T05:08:37+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-11 15:06:21","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7047044","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7047044","identity":"rs-7047044","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}