Early Whole Blood in Patients Requiring Transfusion After Major Trauma
Condition: Trauma/Injury Problem
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposal will assess if patients who require massive transfusion can be accurately
      predicted early after emergency department arrival and assess if the use of stored whole
      blood during initial resuscitation will reduce transfusion needs compared to transfusion with
      component therapy and thus improve outcome.
    

Detailed description: 
      Background: The acquired coagulopathy of trauma is responsible for a large percentage of
      early deaths in civilian trauma practice and is a major cause of battlefield mortality.
      Widespread recognition has provided a rationale for fundamental changes in the initial
      management of severely injured patients through prevention of hypothermia, damage control
      surgery, massive transfusion protocols and early triage to intensive care units for optimized
      resuscitation. Despite these major advances, hemorrhage remains a leading cause of early
      death in both civilian trauma and military combat casualty care. However, it is unclear how
      early whole blood will affect coagulopathy in this cohort of patients as compared to the
      current standard of care. Objective/Hypothesis: The proposal will assess if patients who
      require massive transfusion can be accurately predicted early after emergency department
      arrival and assess if the use of stored whole blood during initial resuscitation will reduce
      transfusion needs compared to transfusion with component therapy and thus improve outcome.

      Study Design: As a first step in testing this hypothesis, we will test commonly utilized
      point of care analysis devices and determine their reliability in predicting transfusion
      requirements in severely injured trauma patients within 20 minutes after arrival in the
      emergency department. Furthermore, we will prospectively randomize severely injured patients
      who require a blood transfusion to receive either stored whole blood and pooled platelets or
      component therapy (packed red blood cells, fresh frozen plasma, and platelets, our current
      standard of care) and compare the ability of stored whole blood to reduce transfusion needs
      and improve clinical outcomes.

      Relevance: Severe uncontrollable coagulopathy in major trauma patients continues to be a
      major determinant of trauma mortalities. The proposed effort aims to provide an early,
      coagulopathy-based prediction model to identify patients at risk for massive transfusion.
      Moreover, our proposal intends to evaluate early stored whole blood transfusion in this at
      risk patient population and determine stored whole blood's ability to prevent or control
      severe coagulopathy compared to standard transfusion care.
    

Intervention name(s): Transfusion of blood products
Intervention type(s): Biological
Intervention description(s): The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transfusion; Whole Blood; Trauma; Coagulopathy; Component Therapy; Civilian; Military