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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02483351 |
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Date of registration:
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25/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome
SAHaRA Pilot |
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Scientific title:
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Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome - A Pilot Randomized Controlled Trial |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02483351 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Canada
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Contacts
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Name:
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Lauralyn McIntyre, MD MSc FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ottawa Hospital Research Institute |
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Name:
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Shane English, MD MSc FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ottawa Hospital Research Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age =18 years old at time of presentation
2. First ever episode aneurysmal SAH
3. Confirmed aneurysmal SAH diagnosis: as confirmed by treating Neurosurgeon or
Neuro-interventionalist and supported by blood in subarachnoid space (demonstrated on
cranial imaging or cerebrospinal fluid positive for xanthochromia) that is the result
of a ruptured saccular aneurysm (confirmed by cranial imaging - cranial topography or
magnetic resonance imaging angiography or catheter angiogram)
4. Incident hemoglobin =100g/L within 14 days following SAH (defined by first day of
hospital presentation)
Exclusion Criteria:
1. Physician and or family decision to withdraw/withhold critical care at time of
enrolment
2. Active bleeding with hemodynamic instability at time of enrolment
3. Patients with contra-indication or known objection to blood transfusions
4. SAH due to causes other than saccular aneurysm rupture including mycotic, traumatic
and dissecting aneurysms, and aneurysms associated with arteriovenous malformations.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Subarachnoid Hemorrhage
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Intervention(s)
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Other: Restrictive Red Blood Cell Transfusion Strategy
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Other: Liberal Red Blood Cell Transfusion Strategy
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Primary Outcome(s)
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Randomization Rate
[Time Frame: 12 months]
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Secondary ID(s)
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20150433-01H
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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