Early Whole Blood in Patients Requiring Transfusion After Major Trauma
Primary Purpose
Trauma/Injury Problem
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Transfusion of blood products
Sponsored by
About this trial
This is an interventional treatment trial for Trauma/Injury Problem focused on measuring Transfusion, Whole Blood, Trauma, Coagulopathy, Component Therapy, Civilian, Military
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older.
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)
- Demonstrate evidence of blood loss due to injury, requiring transfusion in the ED.
Exclusion Criteria:
- Death thought to be imminent, suggesting a futile resuscitation effort
- Known or assumed religious objection to blood products
- Do not resuscitate order in place
- Women who present to the ED who are obviously pregnant.
- Patients who appear to the ED wearing the -opt-out‖ bracelet provided at the community consultation.
Sites / Locations
- Memorial Hermann Hospital - Texas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Whole Blood
Component Therapy
Arm Description
Whole Blood plus pooled platelets
Red blood cells, plasma, platelets
Outcomes
Primary Outcome Measures
Units of Blood Products Required During the First 24 Hours After Emergency Department 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
24-hour Mortality
Mortality rate at 24 hours after arrival
30-day Mortality
Evaluate 30-day mortality among those receiving whole blood compared to those receiving component therapy
Full Information
NCT ID
NCT01227005
First Posted
October 20, 2010
Last Updated
May 1, 2018
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
U.S. Army Medical Research and Development Command
1. Study Identification
Unique Protocol Identification Number
NCT01227005
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
U.S. Army Medical Research and Development Command
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma/Injury Problem
Keywords
Transfusion, Whole Blood, Trauma, Coagulopathy, Component Therapy, Civilian, Military
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whole Blood
Arm Type
Active Comparator
Arm Description
Whole Blood plus pooled platelets
Arm Title
Component Therapy
Arm Type
Active Comparator
Arm Description
Red blood cells, plasma, platelets
Intervention Type
Biological
Intervention Name(s)
Transfusion of blood products
Intervention Description
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).
Primary Outcome Measure Information:
Title
Units of Blood Products Required During the First 24 Hours After Emergency Department Admission
Description
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)
Time Frame
first 24 hours after ED admission
Secondary Outcome Measure Information:
Title
24-hour Mortality
Description
Mortality rate at 24 hours after arrival
Time Frame
First 24 hours after ED admission
Title
30-day Mortality
Description
Evaluate 30-day mortality among those receiving whole blood compared to those receiving component therapy
Time Frame
first 30 days after ED admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older.
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)
Demonstrate evidence of blood loss due to injury, requiring transfusion in the ED.
Exclusion Criteria:
Death thought to be imminent, suggesting a futile resuscitation effort
Known or assumed religious objection to blood products
Do not resuscitate order in place
Women who present to the ED who are obviously pregnant.
Patients who appear to the ED wearing the -opt-out‖ bracelet provided at the community consultation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Cotton, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hermann Hospital - Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8676771
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.
Results Reference
background
PubMed Identifier
3172799
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.
Results Reference
background
PubMed Identifier
5333702
Citation
Oberman HA. The indications for transfusion of freshly drawn blood. JAMA. 1967 Jan 9;199(2):93-7. No abstract available.
Results Reference
background
PubMed Identifier
10912871
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.
Results Reference
background
PubMed Identifier
12768106
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.
Results Reference
background
PubMed Identifier
23979267
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. Erratum In: Ann Surg. 2014 Jul;260(1):178.
Results Reference
derived
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Early Whole Blood in Patients Requiring Transfusion After Major Trauma
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