Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2014-08-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Liberal
Liberal transfusion strategy. Patients will have red blood cells transfused only if Hb \< 9.0 g/dL
Liberal transfusion strategy
Patients will have red blood cells transfused only if Hb \< 9.0 g/dL
Restrictive
Restrictive transfusion strategy. Patients will have red blood cells transfused only if Hb \< 7.0 g/dL
Restrictive transfusion strategy
Patients will have red blood cells transfused only if Hb \< 7.0 g/dL
Interventions
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Liberal transfusion strategy
Patients will have red blood cells transfused only if Hb \< 9.0 g/dL
Restrictive transfusion strategy
Patients will have red blood cells transfused only if Hb \< 7.0 g/dL
Eligibility Criteria
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Inclusion Criteria
* Moderate or severe traumatic brain injury, defined as Glasgow coma scale less than or equal to 12 at hospital admission
* Hemoglobin lower than 9.0 g/dL within 7 days from hospital admission
Exclusion Criteria
* Previous neurological sequelae
* Pregnant women
* Jehovah's Witnesses
* Hemorrhagic shock at randomization
* Moribund patients
* Unable to provide consent
18 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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André Luiz Nunes Gobatto
M.D.
Principal Investigators
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André LN Gobatto, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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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:CD002042. doi: 10.1002/14651858.CD002042.pub6.
Gobatto ALN, Solla D, Brasil S, Taccone FS, Carlotti CG Jr, Malbouisson LMS, Paiva WS. Progressive hemorrhagic injury and ischemia after severe traumatic brain injury according to hemoglobin transfusion thresholds: a post-hoc analysis of the transfusion requirements after head trauma trial. Crit Care. 2024 Jul 3;28(1):218. doi: 10.1186/s13054-024-04981-5. No abstract available.
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.
Gobatto ALN, Link MA, Solla DJ, Bassi E, Tierno PF, Paiva W, Taccone FS, Malbouisson LM. Transfusion requirements after head trauma: a randomized feasibility controlled trial. Crit Care. 2019 Mar 12;23(1):89. doi: 10.1186/s13054-018-2273-9.
Other Identifiers
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32520914.3.0000.0068
Identifier Type: -
Identifier Source: org_study_id
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