SAHaRA: A Randomized Controlled Trial

Ottawa Hospital Research Institute

Status: Completed

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Treatments: Other: Restrictive RBC Transfusion Strategy; Other: Liberal RBC Transfusion Strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT03309579

CTO:903

Details and patient eligibility

About

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.

Full 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)

Enrollment: 742 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

742 participants in 2 patient groups

Liberal RBC Transfusion Strategy

Experimental group

Description:

Hemoglobin value of ≤100g/L

Treatment:

Other: Liberal RBC Transfusion Strategy

Restrictive RBC Transfusion Strategy

Active Comparator group

Description:

Hemoglobin value of ≤80g/L

Treatment:

Other: Restrictive RBC Transfusion Strategy