Aneurysmal SubArachnoid Hemorrhage - Red blood cell transfusion And outcome (SAHaRA): a pilot randomized controlled trial
Aneurysmal subarachnoid hemorrhage (aSAH) is the result of a burst artery in the brain. It affects young people (40-60 years), nearly half of whom will die and another third of whom will be left with permanent disability. Although aSAH represents only a portion of all strokes, it leads to a burden of illness and life years lost that is greater than the most common form of stroke and has more than 4 times the health care costs. In the days to weeks following aSAH, the recovering brain is very sensitive and at great risk of further injury and cell death from a lack of blood flow to at-risk areas. This can be worsened by low hemoglobin (red blood cell) levels which is very common in these patients. We know that transfusion to higher hemoglobin levels improves the delivery of oxygen and decreases brain cell death. Whether in practice keeping a higher hemoglobin level improves otherwise terrible outcomes in aSAH has never been properly studied. In a controlled and methodical fashion, we aim to prove that maintaining higher hemoglobin levels in the first 21 days following aSAH amongst those patients who have low hemoglobin, as compared to the usual care of allowing hemoglobin to drop before considering transfusion, will result in less death and better functional outcomes 12 months after their bleed. Prior to embarking upon the necessary large study, we must demonstrate that completing such a study is possible. As such, we propose a small pilot of the large study to demonstrate that: 1) aSAH patients can be recruited into this study at a rate that will ensure timely completion of the large trial; 2) that patients entered into the study will be managed according to the intervention strategy (liberal versus restrictive transfusion trigger) that they are randomly assigned; and 3) that adequate measurement of the planned clinical outcomes for the large trial is attainable.
Principal Investigator / SupervisorENGLISH, Shane
Co-Investigator(s) / TraineeMcINTYRE, Lauralyn A. ALGIRD, Almunder BOUTIN, Amélie CHASSE, Michael DOWLATSHAHI, Dariush FERGUSSON, Dean A. GRIESDALE, Donald KRAMER, Andreas H. LAUZIER, François LUM, Cheemun MARSHALL, Shawn C. PAGLIARELLO, Giuseppe SINCLAIR, John TINMOUTH, Alan T. TURGEON, Alexis F.
InstitutionOttawa Hospital Research Institute
ProgramCanadian Blood Services-CIHR Partnership Operating Grant Program
Total Amount Awarded$157,172
Project Start Date
Project End Date