Clinical trial NCT01227005: Early Whole Blood in Patients Requiring Transfusion After Major Trauma
Official title: Early Whole Blood in Patients Requiring Transfusion After Major Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trauma/Injury Problem
Keywords: Transfusion
Whole Blood
Trauma
Coagulopathy
Component Therapy
Civilian
Military
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2010-10-22
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Units of Blood Products Required During the First 24 Hours After Emergency Department Admission
timeFrame: first 24 hours after ED admission
Secondary outcomes:
measure: 24-hour Mortality
timeFrame: First 24 hours after ED admission
measure: 30-day Mortality
timeFrame: first 30 days after ED admission
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital - Texas Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Bryan Cotton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erber WN, Tan J, Grey D, Lown JA. Use of unrefrigerated fresh whole blood in massive transfusion. Med J Aust. 1996 Jul 1;165(1):11-3. doi: 10.5694/j.1326-5377.1996.tb124809.x.
citation: Mohr R, Martinowitz U, Lavee J, Amroch D, Ramot B, Goor DA. The hemostatic effect of transfusing fresh whole blood versus platelet concentrates after cardiac operations. J Thorac Cardiovasc Surg. 1988 Oct;96(4):530-4.
citation: Oberman HA. The indications for transfusion of freshly drawn blood. JAMA. 1967 Jan 9;199(2):93-7. No abstract available.
citation: Grosso SM, Keenan JO. Whole blood transfusion for exsanguinating coagulopathy in a US field surgical hospital in postwar Kosovo. J Trauma. 2000 Jul;49(1):145-8. doi: 10.1097/00005373-200007000-00022.
citation: Ledgerwood AM, Lucas CE. A review of studies on the effects of hemorrhagic shock and resuscitation on the coagulation profile. J Trauma. 2003 May;54(5 Suppl):S68-74. doi: 10.1097/01.TA.0000064513.59253.70.
citation: Cotton BA, Podbielski J, Camp E, Welch T, del Junco D, Bai Y, Hobbs R, Scroggins J, Hartwell B, Kozar RA, Wade CE, Holcomb JB; Early Whole Blood Investigators. A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions. Ann Surg. 2013 Oct;258(4):527-32; discussion 532-3. doi: 10.1097/SLA.0b013e3182a4ffa0.