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

August 2, 2023 updated by: American Burn Association

A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

347

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2B 7
        • University of Alberta
    • Ontario
      • Toronto, Ontario, Canada, M4J2N4
        • Sunnybrook Health Science Center
  • New Zealand
      • Auckland, New Zealand, 1640
        • New Zealand National Burn Centre-Middlemore Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008-4973
        • Maricopa Integrated Health System (Arizona Burn Center)
    • California
      • Colton, California, United States, 92324
        • Arrowhead Regional Medical Center
      • Fresno, California, United States, 93721
        • Community Regional Medical Center
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center-Regional Burn Center
      • San Diego, California, United States, 92103
        • University of California, San Diego
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Burn Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Health Science
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Doctors Hospital-Joseph M Still Burn Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill (Jaycee Burn Center)
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University
    • Oregon
      • Portland, Oregon, United States, 97232
        • Oregon Burn Center Legacy Health System
    • Texas
      • Dallas, Texas, United States, 75390-9158
        • University of Texas Southwestern Medical Center
      • Fort Sam Houston, Texas, United States, 78234
        • U.S. Army Institute of Surgical Research (USAISR)
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Intermountain School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Liberal
Maintain hemoglobin at 10-11 g/dL
Other: Liberal transfusion threshold
Maintain hemoglobin at 10-11 g/dL
Active Comparator: Restrictive
Maintain hemoglobin at 7-8 g/dL
Other: Restrictive transfusion threshold
maintain hemoglobin at 7-8 g/dL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Blood Stream Infection
Time Frame: 1 week after randomization and weekly thereafter through discarge from hospital
1 week after randomization and weekly thereafter through discarge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Burn Association

Collaborators

U.S. Army Medical Research and Development Command

Investigators

  • Principal Investigator: Tina L Palmieri, MD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2010

Primary Completion (Actual)

September 28, 2016

Study Completion (Actual)

September 28, 2016

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimated)

March 3, 2010

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABA-MCTG-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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