SAHaRA: A Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome (SAHaRA): A Randomized Controlled Trial

Conditions
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Subarachnoid Hemorrhage, Aneurysmal

Intervention / Treatment
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* Other: Liberal RBC Transfusion Strategy
* Other: Restrictive RBC Transfusion Strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicentre pragmatic, open-label blinded-endpoint
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liberal RBC Transfusion Strategy<br>Hemoglobin value of ≤100g/L | Other: Liberal RBC Transfusion Strategy<br>* RBC transfusion is triggered by a Hemoglobin value of ≤100g/L<br>|
| Active Comparator: Restrictive RBC Transfusion Strategy<br>Hemoglobin value of ≤80g/L | Other: Restrictive RBC Transfusion Strategy<br>* Optional RBC transfusion is triggered by a Hemoglobin value of ≤80g/L<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aneurysmal subarachnoid hemorrhage (aSAH), Red Blood Cell Transfusion (RBC), Vasospasm, Intracranial Hemorrhages, Cardiovascular Diseases