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

Study Overview
=================
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.

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

Conditions
-----------------
Burn Injury

Intervention / Treatment
-----------------
* Other: Restrictive transfusion threshold
* Other: Liberal transfusion threshold


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burn, Transfusion, blood, hemoglobin