The Effects of Sodium Fructose Diphosphate on Blood Coagulation Reaction Time and Plasma Coagulation Factor Activity Tests in vitro

Objective To investigate the effects of sodium fructose diphosphate (FDP) on blood coagulation parameters, including reaction time and plasma coagulation factor activity, in both in vitro and in vivo models.

Three thromboelastography systems (Maiketian, Lepu, Dingrun) were used to assess coagulation parameters (reaction time [R], clotting time [K], α-angle, maximal amplitude [MA]) in blood samples spiked with varying FDP concentrations. An automatic coagulation analyzer quantified the activities of coagulation factors II, V, VII, VIII, IX, X, XI, and XII in FDP-treated plasma.Differences between FDP-treated and control groups were statistically compared. Linear regression analyzed correlations between FDP concentrations and coagulation parameters. For in vivo studies, New Zealand white rabbits received intravenous FDP (0.5, 1, 2, or 4 g/kg), and thromboelastography parameters were monitored at multiple time points post-administration (0.5-2 hours).

Thromboelastography demonstrated a strong positive correlation between FDP concentration and R values across all systems (P 0.05). In vitro experiments revealed significant negative correlations between FDP concentration and activities of factors V (r = -0.995), VII (r = -0.990), IX (r = -0.989), XI (r = -0.997), and XII (r = -0.995) (P 0.05). In vivo administration demonstrated dose-dependent prolongation of R-time, reaching statistical significance (p < 0.05) at:0.5 g/kg: 0.5 hr post-dose,1 g/kg: 0.5-1.5 hr,2 g/kg: 0.5-1.5 hr,4 g/kg: 0.5-2 hr.

FDP significantly impacts coagulation testing outcomes both in vitro and in vivo, potentially through modulation of intrinsic pathway factors (V, VII, IX, XI, XII) and direct interference with clot initiation. These findings suggest clinically relevant anticoagulant properties that warrant further investigation. Competing Interest Statement The authors have declared no competing interest. Funding Statement Yes Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was conducted in vitro and has no adverse effects on patients’ health, because the samples was randomly collected from 11 volunteers and experimenters did not have direct contact with volunteers. Demographic and clinical data were collected by a questionnaire. The the Ethical Committees of The Anhui No.2 Provincial People's Hospital approved the study [protocol number :No. [(R) 2024-037] and all the participants provided their written informed consent in accordance with the Declaration of Helsinki. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Not Applicable I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Not Applicable I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Not Applicable Data Availability All relevant data are within the manuscript and its Supporting Information files.