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

Not Applicable

Completed

• Conditions: Burn Injury

• 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

Study Timeline

• Study First Submitted: 2010-02-26
• Study Start: 2010-02-28
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-03
• Primary Completion: 2016-09-28
• Study Completion: 2016-09-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-02
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (18)

Maricopa Integrated Health System (Arizona Burn Center); 🇺🇸 Phoenix, Arizona, United States

Arrowhead Regional Medical Center; 🇺🇸 Colton, California, United States

Community Regional Medical Center; 🇺🇸 Fresno, California, United States

University of California Davis Medical Center-Regional Burn Center; 🇺🇸 Sacramento, California, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

Washington Hospital Burn Center; 🇺🇸 Washington, District of Columbia, United States

University of Florida Health Science; 🇺🇸 Gainesville, Florida, United States

Doctors Hospital-Joseph M Still Burn Center; 🇺🇸 Augusta, Georgia, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

University of North Carolina at Chapel Hill (Jaycee Burn Center); 🇺🇸 Chapel Hill, North Carolina, United States

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