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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01079247

Enrollment

347

Registered

2010-03-03

Start date

2010-02-28

Completion date

2016-09-28

Last updated

2023-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Injury

Keywords

Burn, Transfusion, blood, hemoglobin

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.

Interventions

OTHERRestrictive transfusion threshold

maintain hemoglobin at 7-8 g/dL

OTHERLiberal transfusion threshold

Maintain hemoglobin at 10-11 g/dL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Canada, New Zealand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026