A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients
- Conditions
- Burn Injury
- Interventions
- Other: Liberal transfusion thresholdOther: Restrictive transfusion threshold
- Registration Number
- NCT01079247
- Lead Sponsor
- American Burn Association
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 347
- >20% TBSA burn with anticipated operation need on admission as determined by attending physician
- age >18 years
- Admission within 96 hours of injury
- <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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liberal Liberal transfusion threshold Maintain hemoglobin at 10-11 g/dL Restrictive Restrictive transfusion threshold Maintain hemoglobin at 7-8 g/dL
- Primary Outcome Measures
Name Time Method Incidence of Blood Stream Infection 1 week after randomization and weekly thereafter through discarge from hospital
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Community Regional Medical Center
🇺🇸Fresno, California, United States
University of California, San Diego
🇺🇸San Diego, California, United States
New Zealand National Burn Centre-Middlemore Hospital
🇳🇿Auckland, New Zealand
Sunnybrook Health Science Center
🇨🇦Toronto, Ontario, Canada
University of Utah Intermountain School of Medicine
🇺🇸Salt Lake City, Utah, United States
Arrowhead Regional Medical Center
🇺🇸Colton, California, United States
Washington Hospital Burn Center
🇺🇸Washington, District of Columbia, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University of Texas SouthWestern Medical Center
🇺🇸Dallas, Texas, United States
U.S. Army Institute of Surgical Research (USAISR)
🇺🇸Fort Sam Houston, Texas, United States
Maricopa Integrated Health System (Arizona Burn Center)
🇺🇸Phoenix, Arizona, United States
Doctors Hospital-Joseph M Still Burn Center
🇺🇸Augusta, Georgia, United States
University of California Davis Medical Center-Regional Burn Center
🇺🇸Sacramento, California, United States
University of Florida Health Science
🇺🇸Gainesville, Florida, United States
University of North Carolina at Chapel Hill (Jaycee Burn Center)
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Oregon Burn Center Legacy Health System
🇺🇸Portland, Oregon, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States