HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial (HEMOTION)
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| ClinicalTrials.gov Identifier: NCT03260478 |
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Recruitment Status :
Recruiting
First Posted : August 24, 2017
Last Update Posted : August 17, 2022
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Sponsor:
CHU de Quebec-Universite Laval
Collaborators:
Canadian Critical Care Trials Group
Canadian Traumatic Brain Injury Research Consortium
Canadian Institutes of Health Research (CIHR)
Canadian Perioperative Anesthesia Clinical Trials (PACT) Group
Information provided by (Responsible Party):
Dr Alexis Turgeon, CHU de Quebec-Universite Laval
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | August 22, 2017 | |||||||||
| First Posted Date ICMJE | August 24, 2017 | |||||||||
| Last Update Posted Date | August 17, 2022 | |||||||||
| Actual Study Start Date ICMJE | September 1, 2017 | |||||||||
| Estimated Primary Completion Date | March 1, 2023 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
extended Glasgow Outcome Scale (GOSe) [ Time Frame: 6 months ] Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
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| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial | |||||||||
| Official Title ICMJE | HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial | |||||||||
| Brief Summary | Most trauma deaths are related to traumatic brain injury (TBI). Although the management of patients has improved, mortality remains unacceptably high, and half of survivors of moderate and severe TBI are left with major functional impairment. Current management guidelines are based on limited evidence and practice is highly variable. Most acutely ill patients with TBI will develop anemia, which may decrease oxygen delivery to a fragile brain. While clinical practice is moving towards transfusing at low hemoglobin (Hb) levels, experts have expressed concerns regarding restrictive strategies, which may adversely affect clinical outcomes in TBI. Our primary objective is to evaluate the effect of red blood cell (RBC) transfusion thresholds on neurological functional outcome. We hypothesize that a liberal transfusion strategy improves outcomes compared to a restrictive strategy. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Masking Description: Open-label with blinded outcome evaluation. Primary Purpose: Treatment
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Red Blood Cells Transfusion
Transfusion of packed red blood cells unit(s).
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| Study Arms ICMJE |
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| Publications * | Turgeon AF, Fergusson DA, Clayton L, Patton MP, Zarychanski R, English S, Docherty A, Walsh T, Griesdale D, Kramer AH, Scales D, Burns KEA, Boyd JG, Marshall JC, Kutsogiannis DJ, Ball I, Hebert PC, Lamontagne F, Costerousse O, St-Onge M, Lessard Bonaventure P, Moore L, Neveu X, Rigamonti A, Khwaja K, Green RS, Laroche V, Fox-Robichaud A, Lauzier F; HEMOTION Trial Team, the Canadian Critical Care Trials Group, the Canadian Perioperative Anesthesia Clinical Trials Group and the Canadian Traumatic Brain Injury Research Consortium. Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol. BMJ Open. 2022 Oct 10;12(10):e067117. doi: 10.1136/bmjopen-2022-067117. | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Recruiting | |||||||||
| Estimated Enrollment ICMJE |
742 | |||||||||
| Original Estimated Enrollment ICMJE |
712 | |||||||||
| Estimated Study Completion Date ICMJE | November 1, 2023 | |||||||||
| Estimated Primary Completion Date | March 1, 2023 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Brazil, Canada, France, United Kingdom | |||||||||
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| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT03260478 | |||||||||
| Other Study ID Numbers ICMJE | MP-20-2018-3706 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | Dr Alexis Turgeon, CHU de Quebec-Universite Laval | |||||||||
| Original Responsible Party | Alexis Turgeon, CHU de Quebec-Universite Laval, Associate Professor | |||||||||
| Current Study Sponsor ICMJE | CHU de Quebec-Universite Laval | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | CHU de Quebec-Universite Laval | |||||||||
| Verification Date | August 2022 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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