Early Whole Blood in Patients Requiring Transfusion After Major Trauma

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.

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.