A Trial of Restrictive Versus 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.

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Key information

Conditions

Burn Injury Burns Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta, Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restrictive transfusion threshold

Other

maintain hemoglobin at 7-8 g/dL

Liberal transfusion threshold

Other

Maintain hemoglobin at 10-11 g/dL

Primary outcomes

Incidence of Blood Stream Infection

Time frame: 1 week after randomization and weekly thereafter through discarge from hospital

Sponsors and collaborators

Lead sponsor

American Burn Association

Other

Collaborators

U.S. Army Medical Research and Development Command

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2016
Study completion: 2016
First posted: Mar 3, 2010
Registry last updated: Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed