Burn InjuryNCT01079247
A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients
A study testing Restrictive transfusion threshold and Liberal transfusion threshold in people with Burn Injury, run by American Burn Association at 18 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Burn Injury
- What is being tested?
- Restrictive transfusion threshold and Liberal transfusion threshold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 28 Feb 2010to 28 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >20% TBSA burn with anticipated operation need on admission as determined by attending physician
- age >18 years
- Admission within 96 hours of injury
Who cannot join
- <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
Show all 11Show fewer
- 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
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States15 sites
Doctors Hospital-Joseph M Still Burn Center
Augusta, Georgia, 30909
University of North Carolina at Chapel Hill (Jaycee Burn Center)
Chapel Hill, North Carolina, 27599
Arrowhead Regional Medical Center
Colton, California, 92324
University of Texas SouthWestern Medical Center
Dallas, Texas, 75390-9158
U.S. Army Institute of Surgical Research (USAISR)
Fort Sam Houston, Texas, 78234
Community Regional Medical Center
Fresno, California, 93721
University of Florida Health Science
Gainesville, Florida, 32610
University of Kansas Medical Center
Kansas City, Kansas, 66160
Maricopa Integrated Health System (Arizona Burn Center)
Phoenix, Arizona, 85008-4973
Oregon Burn Center Legacy Health System
Portland, Oregon, 97232
University of California Davis Medical Center-Regional Burn Center
Sacramento, California, 95817
University of Utah Intermountain School of Medicine
Salt Lake City, Utah, 84132
University of California, San Diego
San Diego, California, 92103
Washington Hospital Burn Center
Washington D.C., District of Columbia, 20010
Wake Forest University
Winston-Salem, North Carolina, 27157
Canada2 sites
University of Alberta
Edmonton, Alberta, T6G2B 7
Sunnybrook Health Science Center
Toronto, Ontario, M4J2N4
New Zealand1 site
New Zealand National Burn Centre-Middlemore Hospital
Auckland, 1640
About this study
Official title: A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients
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.
- Conditions
- Burn Injury
- Being tested
- Restrictive transfusion threshold, Liberal transfusion threshold
- Keywords
- Burn, Transfusion, blood, hemoglobin
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive transfusion thresholdOther
maintain hemoglobin at 7-8 g/dL
Liberal transfusion thresholdOther
Maintain hemoglobin at 10-11 g/dL
| Study group | Role | What they receive |
|---|---|---|
| Liberal | Active comparator | Maintain hemoglobin at 10-11 g/dL Receives: Other: Liberal transfusion threshold |
| Restrictive | Active comparator | Maintain hemoglobin at 7-8 g/dL Receives: Other: Restrictive transfusion threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Blood Stream Infection
Measured: 1 week after randomization and weekly thereafter through discarge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study start28 Feb 2010
- Primary completion28 Sep 2016
- Study completion28 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Burn Association
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Tina L Palmieri, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079247
- Sponsor's protocol ID
- ABA-MCTG-0001
- Status last verified
- Aug 2023
- First submitted
- 26 Feb 2010
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
PubMed 41114449Carson 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.
PubMed 34932836Gibran 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.
PubMed 34554139Cartotto 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.
PubMed 30234568Palmieri 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.
PubMed 28697050
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients
- ClinicalTrials.gov ID
- NCT01079247
- Acronym / sponsor ID
- ABA-MCTG-0001
- Conditions
- Burn Injury
- Keywords
- Burn, Transfusion, blood, hemoglobin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- American Burn AssociationUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- 28 Feb 2010 (actual)
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal | Active comparator | Other: Liberal transfusion thresholdMaintain hemoglobin at 10-11 g/dL |
| Restrictive | Active comparator | Other: Restrictive transfusion thresholdMaintain hemoglobin at 7-8 g/dL |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >20% TBSA burn with anticipated operation need on admission as determined by attending physician
- age >18 years
- Admission within 96 hours of injury
Key exclusion criteria (11 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restrictive transfusion thresholdmaintain hemoglobin at 7-8 g/dL | Other | Restrictive |
| Liberal transfusion thresholdMaintain hemoglobin at 10-11 g/dL | Other | Liberal |
Primary outcome
Incidence of Blood Stream Infection
Time frame: 1 week after randomization and weekly thereafter through discarge from hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Derived from this study: PubMed 41114449Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
- Derived from this study: PubMed 34932836Carson 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.
- Derived from this study: PubMed 34554139Gibran 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.
- Derived from this study: PubMed 30234568Cartotto 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.
- Derived from this study: PubMed 28697050Palmieri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina L Palmieri, MD principal investigator
University of California, Davis
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restrictive transfusion threshold and Liberal transfusion threshold in people with Burn Injury, run by American Burn Association at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Blood Stream Infection (time frame: 1 week after randomization and weekly thereafter through discarge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01079247, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.