Clinical Research Directory

Prehospital Transfusion Outcomes in Traumatic Hemorrhage: a Prospective Cohort Study

Traumatic injuries can cause severe bleeding, which causes a lot of deaths worldwide that could be prevented. Starting treatment as early as possible has been shown to improve survival, which makes fast care very important. This could mean that giving blood products (like red blood cells and plasma) before patients are transported to the hospital might improve survival. However, research from other countries has shown mixed results concerning the effectiveness of giving blood before the patient has arrived in the hospital as a treatment for bleeding patients. In the Netherlands, the helicopter emergency services supports the ambulance teams in life threatening situations. There are four helicopter services spread across the Netherlands. Among other things they can administer red blood cells and two out of four helicopter emergency service teams can give plasma as well. Although other countries have studied their prehospital transfusion programs, no such research has been done in the Dutch system. This study aims to find out which transfusion strategy works best for adult trauma patients who might have severe bleeding after traumatic injuries in the Netherlands. The goal of this observational study is to find out whether different blood-transfusion approaches used by the helicopter emergency services in the Netherlands helps survival in adult trauma patients with severe bleeding who are treated by the Dutch helicopter emergency services. The main question it aims to answer is: Does using different transfusion strategies change the chance of mortality in the first 24 hours? Participants will receive the care they normally have. The helicopter emergency doctors will note information about the treatment they gave before the patient was transported to the hospital and the research will register information about the treatment and outcomes in the hospital.

Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage

The objective of this multicenter, single-arm, observational study is to determine the feasibility and effectiveness of early administration of FDA-approved, pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) in trauma patients with hemorrhagic shock (HS) and functional hypofibrinogenemia. This study will determine whether rapid point-of-care testing for functional hypofibrinogenemia and availability of a shelf-stable fibrinogen complex (IFC) results in shorter time to administration of fibrinogen replacement and correction of functional hypofibrinogenemia, as compared with historical controls and published literature using conventional cryoprecipitate-AHF (CRYO-AHF). This study aims to: * Demonstrate the feasibility and response to early administration of pre-thawed IFC when ordered during initial resuscitation of severely injured patients with HS and functional hypofibrinogenemia. * Assess the effectiveness of early administration of pre-thawed IFC on correction of functional hypofibrinogenemia and on proximate process measures of resuscitation, including time to hemostasis, time to completion of resuscitation, and total volume of resuscitation. * Assess clinical outcomes in severely injured patients with HS and functional hypofibrinogenemia receiving early administration of pre-thawed IFC.