Early Whole Blood in Patients Requiring Transfusion After Major Trauma
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Trauma/Injury Problem
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Units of Blood Products Required During the First 24 Hours After Emergency Department Admission
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Bryan Cotton
Associate Professor, Surgery
The University of Texas Health Science Center, Houston
Eligibility Criteria
Inclusion Criteria
- •18 years of age or older.
- •Meet Code 3 status; Code 3 is determined by the following criteria (Patients must meet at least one of the following physiologic and/or anatomic criteria):
- •Physiologic criteria indicating high risk or life threatening injuries
- •GCS \<10 (Glasgow Coma Scale)
- •SBP \<90 (Systolic blood pressure)
- •RR \<10 or \>29 (Respiratory rate)
- •HR \>120 (Heart rate)
- •intubated
- •Base Deficit \> 6
- •Anatomic criteria indicating high risk or life threatening injuries
Exclusion Criteria
- •Death thought to be imminent, suggesting a futile resuscitation effort
- •Known or assumed religious objection to blood products
- •Do not resuscitate order in place
- •Women who present to the ED who are obviously pregnant.
- •Patients who appear to the ED wearing the -opt-out‖ bracelet provided at the community consultation.
Outcomes
Primary Outcomes
Units of Blood Products Required During the First 24 Hours After Emergency Department Admission
Time Frame: first 24 hours after ED admission
Compare the ability of whole blood to reduce initial 24-hour transfusion requirements as compared to component therapy (red blood cells, plasma, and platelet units)
Secondary Outcomes
- 24-hour Mortality(First 24 hours after ED admission)
- 30-day Mortality(first 30 days after ED admission)