NCT01079247

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
347

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
3 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

February 28, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2010

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2016

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

6.6 years

First QC Date

February 26, 2010

Last Update Submit

August 2, 2023

Conditions

Burn Injury

Keywords

BurnTransfusionbloodhemoglobin

Outcome Measures

Primary Outcomes (1)

  • Incidence of Blood Stream Infection

    1 week after randomization and weekly thereafter through discarge from hospital

Study Arms (2)

Liberal

ACTIVE COMPARATOR

Maintain hemoglobin at 10-11 g/dL

Other: Liberal transfusion threshold

Restrictive

ACTIVE COMPARATOR

Maintain hemoglobin at 7-8 g/dL

Other: Restrictive transfusion threshold

Interventions

Restrictive transfusion thresholdOTHER

maintain hemoglobin at 7-8 g/dL

Restrictive
Liberal transfusion thresholdOTHER

Maintain hemoglobin at 10-11 g/dL

Liberal

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Maricopa Integrated Health System (Arizona Burn Center)

Phoenix, Arizona, 85008-4973, United States

Location

Arrowhead Regional Medical Center

Colton, California, 92324, United States

Location

Community Regional Medical Center

Fresno, California, 93721, United States

Location

University of California Davis Medical Center-Regional Burn Center

Sacramento, California, 95817, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

Washington Hospital Burn Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida Health Science

Gainesville, Florida, 32610, United States

Location

Doctors Hospital-Joseph M Still Burn Center

Augusta, Georgia, 30909, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

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

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Oregon Burn Center Legacy Health System

Portland, Oregon, 97232, United States

Location

University of Texas SouthWestern Medical Center

Dallas, Texas, 75390-9158, United States

Location

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

Fort Sam Houston, Texas, 78234, United States

Location

University of Utah Intermountain School of Medicine

Salt Lake City, Utah, 84132, United States

Location

University of Alberta

Edmonton, Alberta, T6G2B 7, Canada

Location

Sunnybrook Health Science Center

Toronto, Ontario, M4J2N4, Canada

Location

New Zealand National Burn Centre-Middlemore Hospital

Auckland, 1640, New Zealand

Location

Related Publications (5)

  • 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(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

    PMID: 41114449DERIVED

  • 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.

    PMID: 34932836DERIVED

  • 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.

    PMID: 34554139DERIVED

  • 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.

    PMID: 30234568DERIVED

  • 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.

    PMID: 28697050DERIVED

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Tina L Palmieri, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2010

First Posted

March 3, 2010

Study Start

February 28, 2010

Primary Completion

September 28, 2016

Study Completion

September 28, 2016

Last Updated

August 4, 2023

Record last verified: 2023-08

Locations

NZ(1)CA(2)US(15)