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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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The SAHaRA trial will clarify the role of treating anemia with Red Blood Cell (RBC) transfusion in a unique and vulnerable patient population, and determine whether that impacts on functional outcomes and mortality. It will guide best practice standards and clarify the optimal RBC transfusion strategy in patients with aSAH.
We hypothesize that in adult patients suffering from aSAH and anemia, a liberal RBC transfusion strategy as compared to a restrictive RBC transfusion strategy decreases the combined rate of death and severe disability at 12 months (using the modified Rankin Scale)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberal RBC Transfusion Strategy | Experimental | Hemoglobin value of ≤100g/L |
|
| Restrictive RBC Transfusion Strategy | Active Comparator | Hemoglobin value of ≤80g/L |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liberal RBC Transfusion Strategy | Other | RBC transfusion is triggered by a Hemoglobin value of ≤100g/L |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (mRS) | The Modified Rankin Scale (mRS) is a functional outcome measure in stroke. The interview consists of five sections: Constant Care, Assistance to Attend to Bodily Needs/For Walking, Assistance to Look After Own Affairs, Usual Duties and Activities and Symptoms as a Result of Stroke. The scale is scored from 0 reporting no symptoms at all, to 5 reporting severe disability. Death is indicated by a score of 6. | 12 months post |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure (FIM) | The Functional Independence Measure (FIM) assesses the level of a patient's disability considering the amount of support needed to care for them.Items are scored on the basis of how much assistance is required for the individual to carry out activities of daily living. The FIM is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from 1 to 7. The 2 subscales are then added to give a total FIM score between 18 and 126. The higher the score, the more independent the patient is in performing activities of daily living. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shane English, MD MSc FRCPC | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | United States | ||
| Emory University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41114449 | Derived | 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. | |
| 39655786 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 3, 2020 | Jul 18, 2024 |
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Multicentre pragmatic, open-label blinded-endpoint
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open-label blinded-endpoint
| Restrictive RBC Transfusion Strategy | Other | Optional RBC transfusion is triggered by a Hemoglobin value of ≤80g/L |
|
| 12 months post |
| EuroQOL Quality of Life Scale (EQ5D) | The EQ-5D measures generic health status. There are 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort and Anxiety/Depression which are answered by 5 Problem Levels: None, Slight, Moderate, Severe and Unable. The result is a 5 digit number, 11111 indicating no problem in any dimension to 55555 indicating unable to complete in all dimensions. Quality of life is also assessed on a visual analog scale reported from 0 being the worst imaginable health status to 100 as the best imaginable health status. | 12 months post |
| Red Blood Cell Transfusions | The total number of red blood cell transfusions received. | up to 21 days |
| Daily Hemoglobin | The lowest daily hemoglobin values. | up to 21 days |
| Transfusion-related Complications | Complications such as Acute Respiratory Distress Syndrome (ARDS), cardiovascular failure, cardiac ischemia, deep venous thrombosis, pulmonary embolism, sepsis, and septic shock. | up to 28 days |
| Delayed Cerebral Ischemia and Vasospasm | The incidence and severity of delayed cerebral ischemia and vasospasm. | up to 28 days |
| Cerebral Infarction | The incidence of cerebral infarctions. | up to 28 days |
| Mechanical Ventilation | If required, the duration of mechanical ventilation. | up to 21 days |
| Length of Stay | The length of ICU or hospital stay. | 12 months post |
| Mortality | The number of deaths. | 12 months post |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Nepean Hospital | Kingswood | New South Wales | Australia |
| Prince of Wales Hospital | Randwick | New South Wales | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | Australia |
| Royal Brisbane & Women's Hospital | Herston | Queensland | Australia |
| The Alfred | Melbourne | Victoria | Australia |
| Foothills Medical Center | Calgary | Alberta | Canada |
| University of Alberta Hospital | Edmonton | Alberta | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | Canada |
| Royal Jubilee Hospital | Victoria | British Columbia | Canada |
| Winnipeg Health Sciences Center | Winnipeg | Manitoba | Canada |
| Nova Scotia Health Authority | Halifax | Nova Scotia | Canada |
| Hamilton Health Sciences Center | Hamilton | Ontario | Canada |
| Kingston Health Sciences Centre | Kingston | Ontario | Canada |
| London Health Sciences Center | London | Ontario | Canada |
| Shane English | Ottawa | Ontario | K1Y 4E9 | Canada |
| Sunnybrook Research Institute | Toronto | Ontario | Canada |
| Centre hospitalier de l'Université de Montréal | Montreal | Quebec | Canada |
| Montreal Neurological Institute and Hospital | Montreal | Quebec | Canada |
| Centre hospitalier universitaire de Québec-Université Laval | Québec | Quebec | Canada |
| Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec | Canada |
| English SW, Delaney A, Fergusson DA, Chasse M, Turgeon AF, Lauzier F, Tuttle A, Sadan O, Griesdale DE, Redekop G, Chapman M, Hannouche M, Kramer A, Seppelt I, Udy A, Kutsogiannis DJ, Zarychanski R, D'Aragon F, Boyd JG, Salt G, Bellapart J, Wood G, Cava L, Pickett G, Koffman L, Watpool I, Bass F, Hammond N, Ramsay T, Mallick R, Scales DC, Andersen CR, Fitzgerald E, Talbot P, Dowlatshahi D, Sinclair J, Acker J, Marshall SC, McIntyre L; SAHARA Trial Investigators on behalf of the Canadian Critical Care Trials Group; Canadian Critical Care Trials Group. Liberal or Restrictive Transfusion Strategy in Aneurysmal Subarachnoid Hemorrhage. N Engl J Med. 2025 Mar 13;392(11):1079-1088. doi: 10.1056/NEJMoa2410962. Epub 2024 Dec 9. |
| 34932836 | Derived | 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. |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2024 | Sep 16, 2024 | SAP_002.pdf |
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D020300 | Intracranial Hemorrhages |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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