Demonstrating the safety and efficacy of the Hemafuse device for autotransfusion in a swine model of intraperitoneal pelvic hemorrhage

Abstract Noncompressible hemorrhage, such as pelvic hemorrhage, is associated with a high mortality rate and is a potentially preventable cause of death. Blood transfusion is a critical part of resuscitation, however, the availability or storage of blood products in austere and rural settings can impede or delay necessary transfusion. Similarly, large animal laboratories may also have limited resources, such as no banked animal blood. To minimize the need for donor blood products, blood recovery and autotransfusion can be performed using an intra-operative cell salvage machine. While this technique has proven to be beneficial, it is expensive, requires electricity, and can delay the time of transfusion. Recently, a handheld autotransfusion device was created for rural, remote, or low-resource facilities to return shed blood back to a patient or animal undergoing surgery quickly. To determine the resuscitative feasibility of the device, we sought to develop a swine model of open intraperitoneal pelvic hemorrhage, which is a common clinical scenario in low resource settings where cesarean section is one of the most common operations. The aim of this study is to use a model of pelvic hemorrhage to compare resuscitation strategies encountered in austere environments:Strategy 1 (control arm): a crystalloid-based resuscitation.Strategy 2 (therapeutic arm): salvaged, filtered blood recovered by a novel handheld device.Primary outcome: · Red blood cell mass (hematocrit) at four hours following resuscitation.Secondary outcomes: · Hematologic: complete blood count (WBC, RBC, Hb, Hct, platelet count), free Hb, blood smear, blood culture, and potassium. · Coagulation: thromboelastography (TEG), INR, PT, aPTT, ACT. · Hemodynamic measures: mean arterial pressure and heart rate trends. · Device: time to evacuate blood and time to re-transfusion.