Aneurysmal Subarachnoid Hemorrhage - Red Blood Cell Transfusion and Outcome (SAHaRA): Results of a Pilot Randomized Controlled Trial
CCCF ePoster library. English S. Nov 7, 2018; 234192; 2
Shane English
Shane English
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Abstract
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Introduction: Aneurysmal subarachnoid hemorrhage (aSAH) is an important disease with devastating outcomes.  In aSAH patients with anemia, the administration of red blood cells (RBCs) to the injured brain may optimize oxygen delivery and utilization, but no large and rigorous randomized controlled trial (RCT) has demonstrated that more liberal use of RBCs improve clinical outcomes. Prior to the conduct of a large RCT and in collaboration with the Canadian Critical Care Trials Group, we directed a pilot RCT to assess the feasibility of conducting a large trial comparing two RBC transfusion strategies in patients with aSAH.



Objectives:  The primary feasibility objective was to demonstrate an enrolment rate of >1 patient/center/month.  Secondary feasibility objectives were to achieve >90% adherence to the allocated transfusion thresholds and protocol and ≥ 95% completeness of participant follow-up to one year.



Methods:  We conducted a prospective randomized open-label blinded end-point pilot trial at five academic tertiary care centres. Consenting adult aSAH patients with anemia (hemoglobin (Hb) of ≤ 100 g/L) within 14 days of their initial bleed were randomized via central computer-generated randomization into one of the two treatment arms: a liberal (Hb≤100g/L) or a restrictive RBC transfusion trigger strategy (Hb≤80g/L).  The intervention period was the initial 21 days post aSAH.  Clinical outcome measures, collected at one year post aSAH were described in aggregate and included the modified Rankin Scale (mRS), the Functional Independence Measure® (FIM) and the EuroQual-5D-5L (EQ5D) scale.



Results:  Of 129 potentially eligible patients, 88 met eligibility criteria and 60 were randomized between October 2015 and November 2016. These 60 patients were predominantly female (87%), with a mean age of 59 years (±13) and had a median modified Fisher Scale score of 4 (interquartile rand (IQR)=3-4). We recruited a mean of 1.2 patients/center/month.  Transfusion thresholds were adhered to 92% (89 of 97 RBC transfusion episodes) of the time. Furthermore, 85% of allocated transfusions were administered within 6 hours after reaching the transfusion threshold and 100% within 24 hours. 12-month follow-up was 98% (1 loss to follow-up).  Overall, separation of nadir daily Hb values was achieved by post-admission day 3. The mean pre-transfusion Hb difference between groups was 21.1 g/L (standard deviation ±6.5). Among the overall cohort, poor neurologic functional outcome at 12-months (defined as mRS score of 4-6) was observed in 35.1% (95% CI: 22-47%). Amongst the 40 survivors in the entire cohort, 15% (±5%) and 21% (±6%) reported needing help in one or more of the 13 motor domains and 5 cognitive domains of the FIM® respectively. An effect on the quality of life in each of the 5 domains in the EQ5D was observed in 54% (±11%) and self-reported health using the EQ5D visual analogue scale at 12 months was 69 (±22) on a scale of 100.



Conclusions:  In our pilot RCT, we showed the feasibility of conducting a large pragmatic RCT comparing 2 RBC transfusion strategies in aSAH. This trial, powered to clinically important outcomes, is currently underway (NCT03309579).

 

Funding:  This study was funded through a partnership between Canadian Institutes of Health Research and Canadian Blood Services.


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