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A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients

Primary Purpose

Burn Injury

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Restrictive transfusion threshold
Liberal transfusion threshold
Sponsored by
American Burn Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Injury focused on measuring Burn, Transfusion, blood, hemoglobin

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >20% TBSA burn with anticipated operation need on admission as determined by attending physician
  • age >18 years
  • Admission within 96 hours of injury

Exclusion Criteria:

  • <18 years of age
  • pregnancy
  • inability or unwillingness to receive blood products
  • history of chronic anemia (hemoglobin <9.0 g/dL one month prior to enrollment)
  • preexisting need for hemodialysis
  • brain death or imminent brain death
  • non-survivable burn as determined by the attending burn surgeon
  • angina or acute myocardial infarction
  • preexisting hematologic disease
  • Length of hospital stay anticipated to be < 2 weeks
  • Transfusion administered at outside hospital before admit

Sites / Locations

  • Maricopa Integrated Health System (Arizona Burn Center)
  • Arrowhead Regional Medical Center
  • Community Regional Medical Center
  • University of California Davis Medical Center-Regional Burn Center
  • University of California, San Diego
  • Washington Hospital Burn Center
  • University of Florida Health Science
  • Doctors Hospital-Joseph M Still Burn Center
  • University of Kansas Medical Center
  • University of North Carolina at Chapel Hill (Jaycee Burn Center)
  • Wake Forest University
  • Oregon Burn Center Legacy Health System
  • University of Texas SouthWestern Medical Center
  • U.S. Army Institute of Surgical Research (USAISR)
  • University of Utah Intermountain School of Medicine
  • University of Alberta
  • Sunnybrook Health Science Center
  • New Zealand National Burn Centre-Middlemore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Liberal

Restrictive

Arm Description

Maintain hemoglobin at 10-11 g/dL

Maintain hemoglobin at 7-8 g/dL

Outcomes

Primary Outcome Measures

Incidence of Blood Stream Infection

Secondary Outcome Measures

Full Information

First Posted
February 26, 2010
Last Updated
August 2, 2023
Sponsor
American Burn Association
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT01079247
Brief Title
A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients
Official Title
A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 28, 2010 (Actual)
Primary Completion Date
September 28, 2016 (Actual)
Study Completion Date
September 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Burn Association
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to find out if burn injured patients do better receiving fewer blood transfusions than what is traditionally given. We traditionally provide blood transfusions to maintain a hemoglobin level, which is an indicator of the level of red blood cells that carry oxygen in your body, to above 10 g/dl (g/dl stands for grams per deciliter and is the standard measurement used to indicate the level of red blood cells in your blood). However, a preliminary study indicated that maintaining the hemoglobin level to above 7-8 g/dl with less blood transfusion, as compared to a hemoglobin level of 10 g/dl and above, would reduce the occurrence of blood infection, duration on the respirator and length of hospital stay, yet would achieve similar survival in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Injury
Keywords
Burn, Transfusion, blood, hemoglobin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
347 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liberal
Arm Type
Active Comparator
Arm Description
Maintain hemoglobin at 10-11 g/dL
Arm Title
Restrictive
Arm Type
Active Comparator
Arm Description
Maintain hemoglobin at 7-8 g/dL
Intervention Type
Other
Intervention Name(s)
Restrictive transfusion threshold
Intervention Description
maintain hemoglobin at 7-8 g/dL
Intervention Type
Other
Intervention Name(s)
Liberal transfusion threshold
Intervention Description
Maintain hemoglobin at 10-11 g/dL
Primary Outcome Measure Information:
Title
Incidence of Blood Stream Infection
Time Frame
1 week after randomization and weekly thereafter through discarge from hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >20% TBSA burn with anticipated operation need on admission as determined by attending physician age >18 years Admission within 96 hours of injury Exclusion Criteria: <18 years of age pregnancy inability or unwillingness to receive blood products history of chronic anemia (hemoglobin <9.0 g/dL one month prior to enrollment) preexisting need for hemodialysis brain death or imminent brain death non-survivable burn as determined by the attending burn surgeon angina or acute myocardial infarction preexisting hematologic disease Length of hospital stay anticipated to be < 2 weeks Transfusion administered at outside hospital before admit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina L Palmieri, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maricopa Integrated Health System (Arizona Burn Center)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008-4973
Country
United States
Facility Name
Arrowhead Regional Medical Center
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
Community Regional Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
University of California Davis Medical Center-Regional Burn Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Washington Hospital Burn Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida Health Science
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Doctors Hospital-Joseph M Still Burn Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of North Carolina at Chapel Hill (Jaycee Burn Center)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Oregon Burn Center Legacy Health System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States
Facility Name
University of Texas SouthWestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9158
Country
United States
Facility Name
U.S. Army Institute of Surgical Research (USAISR)
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
University of Utah Intermountain School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B 7
Country
Canada
Facility Name
Sunnybrook Health Science Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4J2N4
Country
Canada
Facility Name
New Zealand National Burn Centre-Middlemore Hospital
City
Auckland
ZIP/Postal Code
1640
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
34932836
Citation
Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
Results Reference
derived
PubMed Identifier
34554139
Citation
Gibran NS, Shipper E, Phuong J, Braverman M, Bixby P, Price MA, Bulger EM; NTRAP Burns & Reconstructive Surgery Panel Group. Developing a national trauma research action plan: Results from the Burn Research Gap Delphi Survey. J Trauma Acute Care Surg. 2022 Jan 1;92(1):201-212. doi: 10.1097/TA.0000000000003409.
Results Reference
derived
PubMed Identifier
30234568
Citation
Cartotto R, Taylor SL, Holmes JH 4th, Peck M, Cochran A, King BT, Bhavsar D, Tredget EE, Mozingo D, Greenhalgh D, Pollock BH, Palmieri TL. The Effects of Storage Age of Blood in Massively Transfused Burn Patients: A Secondary Analysis of the Randomized Transfusion Requirement in Burn Care Evaluation Study. Crit Care Med. 2018 Dec;46(12):e1097-e1104. doi: 10.1097/CCM.0000000000003383.
Results Reference
derived
PubMed Identifier
28697050
Citation
Palmieri TL, Holmes JH 4th, Arnoldo B, Peck M, Potenza B, Cochran A, King BT, Dominic W, Cartotto R, Bhavsar D, Kemalyan N, Tredget E, Stapelberg F, Mozingo D, Friedman B, Greenhalgh DG, Taylor SL, Pollock BH. Transfusion Requirement in Burn Care Evaluation (TRIBE): A Multicenter Randomized Prospective Trial of Blood Transfusion in Major Burn Injury. Ann Surg. 2017 Oct;266(4):595-602. doi: 10.1097/SLA.0000000000002408.
Results Reference
derived

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A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients

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