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A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients
This study is ongoing, but not recruiting participants.
Sponsor:
American Burn Association
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
American Burn Association
ClinicalTrials.gov Identifier:
NCT01079247
First received: February 26, 2010
Last updated: December 8, 2016
Last verified: December 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Burn Injury | Other: Restrictive transfusion threshold Other: Liberal transfusion threshold | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Clinical Trial of Restrictive vs. Traditional Blood Transfusion Practices in Burn Patients |
Resource links provided by NLM:
Further study details as provided by American Burn Association:
Primary Outcome Measures:
- Incidence of Blood Stream Infection [ Time Frame: 1 week after randomization and weekly thereafter through discarge from hospital ]
| Enrollment: | 347 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Liberal
Maintain hemoglobin at 10-11 g/dL
|
Other: Liberal transfusion threshold
Maintain hemoglobin at 10-11 g/dL
|
|
Active Comparator: Restrictive
Maintain hemoglobin at 7-8 g/dL
|
Other: Restrictive transfusion threshold
maintain hemoglobin at 7-8 g/dL
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079247
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079247
Locations
| United States, Arizona | |
| Maricopa Integrated Health System (Arizona Burn Center) | |
| Phoenix, Arizona, United States, 85008-4973 | |
| United States, California | |
| Arrowhead Regional Medical Center | |
| Colton, California, United States, 92324 | |
| Community Regional Medical Center | |
| Fresno, California, United States, 93721 | |
| University of California Davis Medical Center-Regional Burn Center | |
| Sacramento, California, United States, 95817 | |
| University of California, San Diego | |
| San Diego, California, United States, 92103 | |
| United States, District of Columbia | |
| Washington Hospital Burn Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| University of Florida Health Science | |
| Gainesville, Florida, United States, 32610 | |
| United States, Georgia | |
| Doctors Hospital-Joseph M Still Burn Center | |
| Agusta, Georgia, United States, 30909 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill (Jaycee Burn Center) | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Wake Forest University | |
| Wiston Salem, North Carolina, United States, 27157 | |
| United States, Oregon | |
| Oregon Burn Center Legacy Health System | |
| Portland, Oregon, United States, 97232 | |
| United States, Texas | |
| University of Texas SouthWestern Medical Center | |
| Dallas, Texas, United States, 75390-9158 | |
| U.S. Army Institute of Surgical Research (USAISR) | |
| Fort Sam Houston, Texas, United States, 78234 | |
| United States, Utah | |
| University of Utah Intermountain School of Medicine | |
| Salt Lake City, Utah, United States, 84132 | |
| Canada, Alberta | |
| University of Alberta | |
| Edmonton, Alberta, Canada, T6G2B 7 | |
| Canada, Ontario | |
| Sunnybrook Health Science Center | |
| Toronto, Ontario, Canada, M4J2N4 | |
| New Zealand | |
| New Zealand National Burn Centre-Middlemore Hospital | |
| Auckland, New Zealand, 1640 | |
Sponsors and Collaborators
American Burn Association
U.S. Army Medical Research and Materiel Command
Investigators
| Principal Investigator: | Tina L Palmieri, MD | University of California, Davis |
More Information
| Responsible Party: | American Burn Association |
| ClinicalTrials.gov Identifier: | NCT01079247 History of Changes |
| Other Study ID Numbers: |
ABA-MCTG-0001 |
| Study First Received: | February 26, 2010 |
| Last Updated: | December 8, 2016 |
Keywords provided by American Burn Association:
|
Burn Transfusion blood hemoglobin |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries Benzocaine Anesthetics, Local Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on July 14, 2017