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

NCT ID: NCT01079247

Last Updated: 2023-08-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2016-09-28

Brief Summary

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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.

Detailed Description

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Conditions

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Burn Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liberal

Maintain hemoglobin at 10-11 g/dL

Group Type ACTIVE_COMPARATOR

Liberal transfusion threshold

Intervention Type OTHER

Maintain hemoglobin at 10-11 g/dL

Restrictive

Maintain hemoglobin at 7-8 g/dL

Group Type ACTIVE_COMPARATOR

Restrictive transfusion threshold

Intervention Type OTHER

maintain hemoglobin at 7-8 g/dL

Interventions

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Restrictive transfusion threshold

maintain hemoglobin at 7-8 g/dL

Intervention Type OTHER

Liberal transfusion threshold

Maintain hemoglobin at 10-11 g/dL

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Army Medical Research and Development Command

FED

Sponsor Role collaborator

American Burn Association

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Arrowhead Regional Medical Center

Colton, California, United States

Site Status

Community Regional Medical Center

Fresno, California, United States

Site Status

University of California Davis Medical Center-Regional Burn Center

Sacramento, California, United States

Site Status

University of California, San Diego

San Diego, California, United States

Site Status

Washington Hospital Burn Center

Washington D.C., District of Columbia, United States

Site Status

University of Florida Health Science

Gainesville, Florida, United States

Site Status

Doctors Hospital-Joseph M Still Burn Center

Augusta, Georgia, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

University of North Carolina at Chapel Hill (Jaycee Burn Center)

Chapel Hill, North Carolina, United States

Site Status

Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Oregon Burn Center Legacy Health System

Portland, Oregon, United States

Site Status

University of Texas SouthWestern Medical Center

Dallas, Texas, United States

Site Status

U.S. Army Institute of Surgical Research (USAISR)

Fort Sam Houston, Texas, United States

Site Status

University of Utah Intermountain School of Medicine

Salt Lake City, Utah, United States

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Sunnybrook Health Science Center

Toronto, Ontario, Canada

Site Status

New Zealand National Burn Centre-Middlemore Hospital

Auckland, , New Zealand

Site Status

Countries

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United States Canada New Zealand

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.

Reference Type DERIVED
PMID: 41114449 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34932836 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34554139 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30234568 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28697050 (View on PubMed)

Other Identifiers

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ABA-MCTG-0001

Identifier Type: -

Identifier Source: org_study_id

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