Clinical trial NCT01079247: A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients
Official title: A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Injury
Keywords: Burn
Transfusion
blood
hemoglobin
Lead sponsor: American Burn Association
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2010-03-03
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of Blood Stream Infection
timeFrame: 1 week after randomization and weekly thereafter through discarge from hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Integrated Health System (Arizona Burn Center)
state: Arizona
city: Colton
country: United States
facility: Arrowhead Regional Medical Center
state: California
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center-Regional Burn Center
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Washington
country: United States
facility: Washington Hospital Burn Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Health Science
state: Florida
city: Augusta
country: United States
facility: Doctors Hospital-Joseph M Still Burn Center
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill (Jaycee Burn Center)
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Portland
country: United States
facility: Oregon Burn Center Legacy Health System
state: Oregon
city: Dallas
country: United States
facility: University of Texas SouthWestern Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: U.S. Army Institute of Surgical Research (USAISR)
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Intermountain School of Medicine
state: Utah
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Toronto
country: Canada
facility: Sunnybrook Health Science Center
state: Ontario
city: Auckland
country: New Zealand
facility: New Zealand National Burn Centre-Middlemore Hospital
Study officials:
affiliation: University of California, Davis
name: Tina L Palmieri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
citation: Gibran NS, Shipper E, Phuong J, Braverman M, Bixby P, Price MA, Bulger EM; NTRAP Burns & Reconstructive Surgery Panel Group. Developing a national trauma research action plan: Results from the Burn Research Gap Delphi Survey. J Trauma Acute Care Surg. 2022 Jan 1;92(1):201-212. doi: 10.1097/TA.0000000000003409.
citation: Cartotto R, Taylor SL, Holmes JH 4th, Peck M, Cochran A, King BT, Bhavsar D, Tredget EE, Mozingo D, Greenhalgh D, Pollock BH, Palmieri TL. The Effects of Storage Age of Blood in Massively Transfused Burn Patients: A Secondary Analysis of the Randomized Transfusion Requirement in Burn Care Evaluation Study. Crit Care Med. 2018 Dec;46(12):e1097-e1104. doi: 10.1097/CCM.0000000000003383.
citation: Palmieri TL, Holmes JH 4th, Arnoldo B, Peck M, Potenza B, Cochran A, King BT, Dominic W, Cartotto R, Bhavsar D, Kemalyan N, Tredget E, Stapelberg F, Mozingo D, Friedman B, Greenhalgh DG, Taylor SL, Pollock BH. Transfusion Requirement in Burn Care Evaluation (TRIBE): A Multicenter Randomized Prospective Trial of Blood Transfusion in Major Burn Injury. Ann Surg. 2017 Oct;266(4):595-602. doi: 10.1097/SLA.0000000000002408.