Early Whole Blood in Patients Requiring Transfusion After Major Trauma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Trauma/Injury Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Whole Blood

Whole Blood plus pooled platelets

Group Type ACTIVE_COMPARATOR

Transfusion of blood products

Intervention Type BIOLOGICAL

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).

Component Therapy

Red blood cells, plasma, platelets

Group Type ACTIVE_COMPARATOR

Transfusion of blood products

Intervention Type BIOLOGICAL

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).

Interventions

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Transfusion of blood products

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).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No