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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
742
RBC transfusion is triggered by a Hemoglobin value of ≤100g/L
Optional RBC transfusion is triggered by a Hemoglobin value of ≤80g/L
University of Colorado School of Medicine
Aurora, Colorado, United States
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.
Time frame: 12 months post
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.
Time frame: 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.
Time frame: 12 months post
Red Blood Cell Transfusions
The total number of red blood cell transfusions received.
Time frame: up to 21 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Emory University School of Medicine
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Nepean Hospital
Kingswood, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia
The Alfred
Melbourne, Victoria, Australia
Foothills Medical Center
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
...and 13 more locations
Daily Hemoglobin
The lowest daily hemoglobin values.
Time frame: 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.
Time frame: up to 28 days
Delayed Cerebral Ischemia and Vasospasm
The incidence and severity of delayed cerebral ischemia and vasospasm.
Time frame: up to 28 days
Cerebral Infarction
The incidence of cerebral infarctions.
Time frame: up to 28 days
Mechanical Ventilation
If required, the duration of mechanical ventilation.
Time frame: up to 21 days
Length of Stay
The length of ICU or hospital stay.
Time frame: 12 months post
Mortality
The number of deaths.
Time frame: 12 months post