SAHaRA: A Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT03309579|
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : September 16, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage, Aneurysmal||Other: Liberal RBC Transfusion Strategy Other: Restrictive RBC Transfusion Strategy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||740 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Multicentre pragmatic, open-label blinded-endpoint|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||open-label blinded-endpoint|
|Official Title:||Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome (SAHaRA): A Randomized Controlled Trial|
|Actual Study Start Date :||February 12, 2018|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2024|
Experimental: Liberal RBC Transfusion Strategy
Hemoglobin value of ≤100g/L
Other: Liberal RBC Transfusion Strategy
RBC transfusion is triggered by a Hemoglobin value of ≤100g/L
Active Comparator: Restrictive RBC Transfusion Strategy
Hemoglobin value of ≤80g/L
Other: Restrictive RBC Transfusion Strategy
Optional RBC transfusion is triggered by a Hemoglobin value of ≤80g/L
- Modified Rankin Scale (mRS) [ Time Frame: 12 months post ]
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.
- Functional Independence Measure (FIM) [ Time Frame: 12 months post ]
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.
- EuroQOL Quality of Life Scale (EQ5D) [ Time Frame: 12 months post ]
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.
- Red Blood Cell Transfusions [ Time Frame: up to 21 days ]The total number of red blood cell transfusions received.
- Daily Hemoglobin [ Time Frame: up to 21 days ]The lowest daily hemoglobin values.
- Transfusion-related Complications [ Time Frame: up to 28 days ]Complications such as Acute Respiratory Distress Syndrome (ARDS), cardiovascular failure, cardiac ischemia, deep venous thrombosis, pulmonary embolism, sepsis, and septic shock.
- Delayed Cerebral Ischemia and Vasospasm [ Time Frame: up to 28 days ]The incidence and severity of delayed cerebral ischemia and vasospasm.
- Cerebral Infarction [ Time Frame: up to 28 days ]The incidence of cerebral infarctions.
- Mechanical Ventilation [ Time Frame: up to 21 days ]If required, the duration of mechanical ventilation.
- Length of Stay [ Time Frame: 12 months post ]The length of ICU or hospital stay.
- Mortality [ Time Frame: 12 months post ]The number of deaths.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age ≥18 years old at time of SAH
- First ever episode of aneurysmal SAH
- Diagnosis of aSAH as confirmed by treating physician (eg: neurosurgeon or neuro- interventionalist) and supported by blood in subarachnoid space (e.g. cranial imaging or cerebrospinal fluid positive for xanthochromia, surgical visualization) that is the result of a ruptured aneurysm (e.g. direct visualization, cranial imaging or catheter angiogram)
- Hb ≤100g/L within 10 days following aSAH (defined by first day of hospital presentation)
- Physician and or family decision to withdraw/withhold active medical care at time of enrolment
- Active bleeding with hemodynamic instability at time of enrolment
- Patients with contraindication or known objection to blood transfusions
- SAH due to mycotic aneurysm, infundibulum and vascular malformations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309579
|Contact: Shane English, MD MSc FRCPC||(613) 737-8899 ext email@example.com|
|Principal Investigator:||Shane English, MD MSc FRCPC||Ottawa Hospital Research Institute|
|Responsible Party:||Ottawa Hospital Research Institute|
|Other Study ID Numbers:||
|First Posted:||October 13, 2017 Key Record Dates|
|Last Update Posted:||September 16, 2021|
|Last Verified:||September 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Aneurysmal subarachnoid hemorrhage (aSAH)
Red Blood Cell Transfusion (RBC)
Central Nervous System Diseases
Nervous System Diseases