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

Burn Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079247
• Other study ID #: ABA-MCTG-0001
• Status: Completed
• Phase: N/A
• Start date: February 28, 2010
• Est. completion date: September 28, 2016

Study information

• Verified date: August 2023
• Source: American Burn Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: September 28, 2016
• Est. primary completion date: September 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Injury
• Burns

Intervention

Other:
• Restrictive transfusion threshold
maintain hemoglobin at 7-8 g/dL
• Liberal transfusion threshold
Maintain hemoglobin at 10-11 g/dL

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Sunnybrook Health Science Center	Toronto	Ontario
New Zealand	New Zealand National Burn Centre-Middlemore Hospital	Auckland
United States	Doctors Hospital-Joseph M Still Burn Center	Augusta	Georgia
United States	University of North Carolina at Chapel Hill (Jaycee Burn Center)	Chapel Hill	North Carolina
United States	Arrowhead Regional Medical Center	Colton	California
United States	University of Texas SouthWestern Medical Center	Dallas	Texas
United States	U.S. Army Institute of Surgical Research (USAISR)	Fort Sam Houston	Texas
United States	Community Regional Medical Center	Fresno	California
United States	University of Florida Health Science	Gainesville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Maricopa Integrated Health System (Arizona Burn Center)	Phoenix	Arizona
United States	Oregon Burn Center Legacy Health System	Portland	Oregon
United States	University of California Davis Medical Center-Regional Burn Center	Sacramento	California
United States	University of Utah Intermountain School of Medicine	Salt Lake City	Utah
United States	University of California, San Diego	San Diego	California
United States	Washington Hospital Burn Center	Washington	District of Columbia
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
American Burn Association	U.S. Army Medical Research and Development Command

Countries where clinical trial is conducted

United States,  Canada,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Blood Stream Infection		1 week after randomization and weekly thereafter through discarge from hospital