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SAHaRA: A Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309579
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : April 21, 2023
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage, Aneurysmal Other: Liberal RBC Transfusion Strategy Other: Restrictive RBC Transfusion Strategy Not Applicable

Detailed Description:
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)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 740 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicentre pragmatic, open-label blinded-endpoint
Masking: Single (Outcomes Assessor)
Masking Description: open-label blinded-endpoint
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. Red Blood Cell Transfusions [ Time Frame: up to 21 days ]
    The total number of red blood cell transfusions received.

  4. Daily Hemoglobin [ Time Frame: up to 21 days ]
    The lowest daily hemoglobin values.

  5. 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.

  6. Delayed Cerebral Ischemia and Vasospasm [ Time Frame: up to 28 days ]
    The incidence and severity of delayed cerebral ischemia and vasospasm.

  7. Cerebral Infarction [ Time Frame: up to 28 days ]
    The incidence of cerebral infarctions.

  8. Mechanical Ventilation [ Time Frame: up to 21 days ]
    If required, the duration of mechanical ventilation.

  9. Length of Stay [ Time Frame: 12 months post ]
    The length of ICU or hospital stay.

  10. Mortality [ Time Frame: 12 months post ]
    The number of deaths.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years old at time of SAH
  2. First ever episode of aneurysmal SAH
  3. 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)
  4. Hb ≤100g/L within 10 days following aSAH (defined by first day of hospital presentation)

Exclusion Criteria:

  1. Physician and or family decision to withdraw/withhold active medical care at time of enrolment
  2. Active bleeding with hemodynamic instability at time of enrolment
  3. Patients with contraindication or known objection to blood transfusions
  4. SAH due to mycotic aneurysm, infundibulum and vascular malformations.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Shane English, MD MSc FRCPC (613) 737-8899 ext 72818 senglish@toh.ca

Locations
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Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Shane English, MD MSc FRCPC Ottawa Hospital Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03309579    
Other Study ID Numbers: CTO:903
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: April 21, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Aneurysmal subarachnoid hemorrhage (aSAH)
Red Blood Cell Transfusion (RBC)
Vasospasm
Intracranial Hemorrhages
Cardiovascular Diseases
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases