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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01079247




Registration number
NCT01079247
Ethics application status
Date submitted
26/02/2010
Date registered
3/03/2010
Date last updated
4/08/2023

Titles & IDs
Public title
A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients
Scientific title
A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients
Secondary ID [1] 0 0
ABA-MCTG-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Restrictive transfusion threshold
Other interventions - Liberal transfusion threshold

Active comparator: Liberal - Maintain hemoglobin at 10-11 g/dL

Active comparator: Restrictive - Maintain hemoglobin at 7-8 g/dL


Other interventions: Restrictive transfusion threshold
maintain hemoglobin at 7-8 g/dL

Other interventions: Liberal transfusion threshold
Maintain hemoglobin at 10-11 g/dL
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Blood Stream Infection
Timepoint [1] 0 0
1 week after randomization and weekly thereafter through discarge from hospital

Eligibility
Key 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
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/09/2016
Sample size
Target
Accrual to date
Final
347
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
New Zealand
State/province [13] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
American Burn Association
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
U.S. Army Medical Research and Development Command
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01079247
Trial related presentations / publications
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Tina L Palmieri, MD
Address 0 0
University of California, Davis
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01079247