Early Whole Blood in Patients Requiring Transfusion After Major Trauma

Phase 4

Completed

• Conditions: Trauma/Injury Problem
• Interventions: Biological: Transfusion of blood products

• Registration Number: NCT01227005
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Study Timeline

• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-22
• Study Start: 2011-05
• Primary Completion: 2012-08
• Study Completion: 2012-12
• Results First Submitted: 2014-05-19
• Results First Submitted QC: 2015-05-26
• Results First Posted: 2015-05-28
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

1. 18 years of age or older.

2. 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
   • Any penetrating injury to torso, groin, or neck
   • Amputation proximal to the ankle or wrist
   • Uncontrolled external hemorrhage
   • Two or more long bone fractures
   • Pelvic fracture
   • Paraplegia or quadriplegia
   • Combination trauma with burns ≥ 20% BSA (body surface area)

3. Demonstrate evidence of blood loss due to injury, requiring transfusion in the ED.

Exclusion Criteria

1. Death thought to be imminent, suggesting a futile resuscitation effort
2. Known or assumed religious objection to blood products
3. Do not resuscitate order in place
4. Women who present to the ED who are obviously pregnant.
5. Patients who appear to the ED wearing the -opt-out‖ bracelet provided at the community consultation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole Blood	Transfusion of blood products	Whole Blood plus pooled platelets
Component Therapy	Transfusion of blood products	Red blood cells, plasma, platelets

Primary Outcome Measures

Name	Time	Method
Units of Blood Products Required During the First 24 Hours After Emergency Department Admission	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 Outcome Measures

Name	Time	Method
24-hour Mortality	First 24 hours after ED admission	Mortality rate at 24 hours after arrival
30-day Mortality	first 30 days after ED admission	Evaluate 30-day mortality among those receiving whole blood compared to those receiving component therapy

Trial Locations

Locations (1)

Memorial Hermann Hospital - Texas Medical Center; 🇺🇸 Houston, Texas, United States