SAHaRA: A Randomized Controlled Trial

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03309579
• Other study ID #: CTO:903
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 12, 2018
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 740
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Intervention

Other:
• Liberal RBC Transfusion Strategy
RBC transfusion is triggered by a Hemoglobin value of =100g/L
• Restrictive RBC Transfusion Strategy
Optional RBC transfusion is triggered by a Hemoglobin value of =80g/L

Locations

Country	Name	City	State
Australia	The George Institute	Newtown	New South Wales
Canada	Foothills Medical Center	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton Health Sciences Center	Hamilton	Ontario
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	London Health Sciences Center	London	Ontario
Canada	Centre hospitalier de l'Université de Montréal	Montréal	Quebec
Canada	Montreal Neurological Institute and Hospital	Montréal	Quebec
Canada	Shane English	Ottawa	Ontario
Canada	Centre hospitalier universitaire de Québec-Université Laval	Québec City	Quebec
Canada	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Sunnybrook Research Institute	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Royal Jubilee Hospital	Victoria	British Columbia
Canada	Winnipeg Health Sciences Center	Winnipeg	Manitoba
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Red Blood Cell Transfusions	The total number of red blood cell transfusions received.	up to 21 days
Secondary	Daily Hemoglobin	The lowest daily hemoglobin values.	up to 21 days
Secondary	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
Secondary	Delayed Cerebral Ischemia and Vasospasm	The incidence and severity of delayed cerebral ischemia and vasospasm.	up to 28 days
Secondary	Cerebral Infarction	The incidence of cerebral infarctions.	up to 28 days
Secondary	Mechanical Ventilation	If required, the duration of mechanical ventilation.	up to 21 days
Secondary	Length of Stay	The length of ICU or hospital stay.	12 months post
Secondary	Mortality	The number of deaths.	12 months post