A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients
NCT ID: NCT01079247
Last Updated: 2023-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
347 participants
INTERVENTIONAL
2010-02-28
2016-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Liberal
Maintain hemoglobin at 10-11 g/dL
Liberal transfusion threshold
Maintain hemoglobin at 10-11 g/dL
Restrictive
Maintain hemoglobin at 7-8 g/dL
Restrictive transfusion threshold
maintain hemoglobin at 7-8 g/dL
Interventions
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Restrictive transfusion threshold
maintain hemoglobin at 7-8 g/dL
Liberal transfusion threshold
Maintain hemoglobin at 10-11 g/dL
Eligibility Criteria
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Inclusion Criteria
* age \>18 years
* Admission within 96 hours of injury
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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U.S. Army Medical Research and Development Command
FED
American Burn Association
OTHER
Responsible Party
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Principal Investigators
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Tina L Palmieri, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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Maricopa Integrated Health System (Arizona Burn Center)
Phoenix, Arizona, United States
Arrowhead Regional Medical Center
Colton, California, United States
Community Regional Medical Center
Fresno, California, United States
University of California Davis Medical Center-Regional Burn Center
Sacramento, California, United States
University of California, San Diego
San Diego, California, United States
Washington Hospital Burn Center
Washington D.C., District of Columbia, United States
University of Florida Health Science
Gainesville, Florida, United States
Doctors Hospital-Joseph M Still Burn Center
Augusta, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of North Carolina at Chapel Hill (Jaycee Burn Center)
Chapel Hill, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Oregon Burn Center Legacy Health System
Portland, Oregon, United States
University of Texas SouthWestern Medical Center
Dallas, Texas, United States
U.S. Army Institute of Surgical Research (USAISR)
Fort Sam Houston, Texas, United States
University of Utah Intermountain School of Medicine
Salt Lake City, Utah, United States
University of Alberta
Edmonton, Alberta, Canada
Sunnybrook Health Science Center
Toronto, Ontario, Canada
New Zealand National Burn Centre-Middlemore Hospital
Auckland, , New Zealand
Countries
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References
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Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10:CD002042. doi: 10.1002/14651858.CD002042.pub6.
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.
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.
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.
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.
Other Identifiers
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ABA-MCTG-0001
Identifier Type: -
Identifier Source: org_study_id
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