Early Whole Blood in Patients Requiring Transfusion After Major Trauma

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Bryan Cotton, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01227005
First received: October 20, 2010
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Trauma/Injury Problem
Biological: Transfusion of blood products
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Whole Blood in Patients Requiring Transfusion After Major Trauma

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • In a prospective, randomized trial, evaluate transfusion of stored whole blood and pooled platelets during transfusion therapy. [ Time Frame: First 24 hours after ED admission ] [ Designated as safety issue: No ]
    A) Compare its ability to reduce transfusion requirements as compared to component therapy (packed red blood cells, fresh frozen plasma, and platelet units) B) Compare overall mortality as compared to component therapy C) Compare incidence of multiple organ failure as compared to component therapy D) Compare the impact of age of blood products on clinical outcomes.


Secondary Outcome Measures:
  • Accurately predict major trauma patients who will require a blood transfusion [ Time Frame: First 24 hours after ED admission ] [ Designated as safety issue: No ]
    A) Prospectively collect protocol data. B) Analyze multiple point of care parameters to assess predictors of massive transfusion.

  • Test commonly utilized point of care analysis and determine its reliability in early prediction of transfusion needs. [ Time Frame: First 24 hours afte ED admission ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Whole Blood
Whole Blood plus pooled platelets
Biological: 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).
Active Comparator: Component Therapy
Red blood cells, plasma, platelets
Biological: 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).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227005

Locations
United States, Texas
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Bryan Cotton, MD The University of Texas Health Science Center, Houston
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bryan Cotton, Associate Professor, Surgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01227005     History of Changes
Other Study ID Numbers: W81XWH-07-1-0229
Study First Received: October 20, 2010
Last Updated: December 17, 2012
Health Authority: United States: Federal Government

Keywords provided by The University of Texas Health Science Center, Houston:
Transfusion
Whole Blood
Trauma
Coagulopathy
Component Therapy
Civilian
Military

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014