Subarachnoid Hemorrhage, Aneurysmal
Conditions
Keywords
Aneurysmal subarachnoid hemorrhage (aSAH), Red Blood Cell Transfusion (RBC), Vasospasm, Intracranial Hemorrhages, Cardiovascular Diseases
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.
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)
Interventions
OTHERLiberal RBC Transfusion Strategy
RBC transfusion is triggered by a Hemoglobin value of ≤100g/L
OTHERRestrictive RBC Transfusion Strategy
Optional RBC transfusion is triggered by a Hemoglobin value of ≤80g/L
Sponsors
Canadian Institutes of Health Research (CIHR)
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
open-label blinded-endpoint
Intervention model description
Multicentre pragmatic, open-label blinded-endpoint
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) | 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
| Measure | Time frame | Description |
|---|---|---|
| EuroQOL Quality of Life Scale (EQ5D) | 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 | up to 21 days | The total number of red blood cell transfusions received. |
| Daily Hemoglobin | up to 21 days | The lowest daily hemoglobin values. |
| Transfusion-related Complications | 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. |
| Functional Independence Measure (FIM) | 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. |
| Cerebral Infarction | up to 28 days | The incidence of cerebral infarctions. |
| Mechanical Ventilation | up to 21 days | If required, the duration of mechanical ventilation. |
| Length of Stay | 12 months post | The length of ICU or hospital stay. |
| Mortality | 12 months post | The number of deaths. |
| Delayed Cerebral Ischemia and Vasospasm | up to 28 days | The incidence and severity of delayed cerebral ischemia and vasospasm. |
Countries
Australia, Canada, United States
Outcome results
None listed