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| Name | Class |
|---|---|
| Canadian Critical Care Trials Group | OTHER |
| Canadian Traumatic Brain Injury Research Consortium | UNKNOWN |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberal Transfusion Strategy | Experimental | Patients will receive red blood cells transfusion if Hb ≤ 100 g/L. |
|
| Restrictive Transfusion Strategy | Experimental | Patients will receive red blood cells transfusion if Hb ≤ 70 g/L. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red Blood Cells Transfusion | Procedure | Transfusion of packed red blood cells unit(s). |
|
| Measure | Description | Time Frame |
|---|---|---|
| extended Glasgow Outcome Scale (GOSe) | Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Assessment of patient mortality. | ICU, Hospital and at 6 months |
| Functional Independence Measure (FIM) | Assessment of patient function. |
| Measure | Description | Time Frame |
|---|---|---|
| Number RBC transfusions | Assessment of the number of RBC transfusions. | While in the ICU, censored at 6 months after randomization |
| Lowest Daily Hemoglobin | Assessment of the Median Lower Daily Hemoglobin. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexis Turgeon, MD MSc FRCPC | CHU de Quebec-Université Laval Research Center | Principal Investigator |
| François Lauzier, MD MSc FRCPC | CHU de Quebec-Université Laval Research Center | Principal Investigator |
| Dean Fergusson, PhD | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Casa de Misericórdia de Barretos | Barretos | São Paulo | Brazil | |||
| The Hospital das Clinicas da Facudade de Medicina da USP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38869931 | Derived | Turgeon AF, Fergusson DA, Clayton L, Patton MP, Neveu X, Walsh TS, Docherty A, Malbouisson LM, Pili-Floury S, English SW, Zarychanski R, Moore L, Bonaventure PL, Laroche V, Verret M, Scales DC, Adhikari NKJ, Greenbaum J, Kramer A, Rey VG, Ball I, Khwaja K, Wise M, Harvey D, Lamontagne F, Chabanne R, Algird A, Krueper S, Pottecher J, Zeiler F, Rhodes J, Rigamonti A, Burns KEA, Marshall J, Griesdale DE, Sisconetto LS, Kutsogiannis DJ, Roger C, Green R, Boyd JG, Wright J, Charbonney E, Nair P, Astles T, Sy E, Hebert PC, Chasse M, Gomez A, Ramsay T, Taljaard M, Fox-Robichaud A, Tinmouth A, St-Onge M, Costerousse O, Lauzier F; HEMOTION Trial Investigators on behalf of the Canadian Critical Care Trials Group, the Canadian Perioperative Anesthesia Clinical Trials Group, and the Canadian Traumatic Brain Injury Research Consortium. Liberal or Restrictive Transfusion Strategy in Patients with Traumatic Brain Injury. N Engl J Med. 2024 Aug 22;391(8):722-735. doi: 10.1056/NEJMoa2404360. Epub 2024 Jun 13. | |
| 36216432 |
| Label | URL |
|---|---|
| Canadian Traumatic Brain Injury Research Consortium website | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 22, 2024 | Mar 5, 2024 |
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| Canadian Perioperative Anesthesia Clinical Trials (PACT) Group |
| UNKNOWN |
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Open-label with blinded outcome evaluation.
| 6 months |
| Quality of life (EQ-5D) | Evaluation of the overall quality of life. | 6 months |
| Quality of life (Qolibri questionnaires) | Evaluation of the quality of life specific to the TBI. | 6 months |
| Depression (PHQ-9) | Assessment of depression. | 6 months |
| While in the ICU, censored at 6 months after randomization |
| Infections | Assessment of the incidence of infections. | While in the ICU, censored at 6 months after randomization |
| Duration of mechanical ventilation | Duration of mechanical ventilation. | While in the ICU, censored at 6 months after randomization |
| ICU Lenght of stay | Lenght of stay in the intensive care unit | While in the ICU, censored at 6 months after randomization |
| Hospital Lenght of stay | Duration of hospitalization is study hospital | While in the hospital, censored at 6 months after randomization |
| Complications related to transfusion | Assessment of complications related to RBC transfusions. | While in the ICU, censored at 6 months after randomization |
| São Paulo |
| Brazil |
| Foothills Medical Center | Calgary | Alberta | Canada |
| Royal Alexandra Hospital | Edmonton | Alberta | Canada |
| University of Alberta Hospital | Edmonton | Alberta | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | Canada |
| Winnipeg Health Sciences Center | Winnipeg | Manitoba | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | Canada |
| Hamilton Health Sciences Center | Hamilton | Ontario | Canada |
| Kingston General Hospital | Kingston | Ontario | Canada |
| London Health Sciences Center | London | Ontario | Canada |
| The Ottawa Hospital | Ottawa | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Sunnybrook Research Institute | Toronto | Ontario | Canada |
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | Canada |
| McGill University Health Center | Montreal | Quebec | Canada |
| CIUSSS De l'Estrie | Sherbrooke | Quebec | Canada |
| CIUSSS Mauricie-et-Centre-du-Québec | Trois-Rivières | Quebec | Canada |
| Regina General Hospital | Regina | Saskatchewan | Canada |
| CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus), Université Laval | Québec | Canada |
| CHU de Clermont-Ferrand | Clermont-Ferrand | Auvergne-Rhône-Alpes | France |
| CHU de Besançon | Besançon | Bourgogne-Franche-Comté | France |
| Hôpital de Hautepierre | Strasbourg | Grand Est | France |
| CHU de Nîmes | Nîmes | Occitanie | France |
| University Hospital of Wales | Cardiff | United Kingdom |
| Western General Hospital | Edinburgh | United Kingdom |
| Aintree University Hospital | Liverpool | United Kingdom |
| Walton Centre | Liverpool | United Kingdom |
| St. Mary's Hospital (Imperial College Healthcare) | London | United Kingdom |
| James Cook University Hospital | Middlesbrough | United Kingdom |
| University of Nottingham Hospital | Nottingham | United Kingdom |
| Salford Royal Hospital | Salford | United Kingdom |
| Royal Stoke University Hospital | Stoke-on-Trent | United Kingdom |
| Derived |
| 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. |
| SAP_001.pdf |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D000740 | Anemia |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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