Aneurysmal SubArachnoid Hemorrhage-Red Blood Cell Transfusion And Outcome (SAHaRA): a pilot randomised controlled trial protocol.

Abstract

INTRODUCTION:

Anaemia is common in aneurysmal subarachnoid haemorrhage (aSAH) and is a potential critical modifiable factor affecting secondary injury. Despite physiological evidence and management guidelines that support maintaining a higher haemoglobin level in patients with aSAH, current practice is one of a more restrictive approach to transfusion. The goal of this multicentre pilot trial is to determine the feasibility of successfully conducting a red blood cell (RBC) transfusion trial in adult patients with acute aSAH and anaemia (Hb ≤100 g/L), comparing a liberal transfusion strategy (Hb ≤100 g/L) with a restrictive strategy (Hb ≤80 g/L) on the combined rate of death and severe disability at 12 months.

METHODS:

Design This is a multicentre open-label randomised controlled pilot trial at 5 academic tertiary care centres. Population We are targeting adult aSAH patients within 14 days of their initial bleed and with anaemia (Hb ≤110 g/L). Randomisation Central computer-generated randomisation, stratified by centre, will be undertaken from the host centre. Randomisation into 1 of the 2 treatment arms will occur when the haemoglobin levels of eligible patients fall to ≤100 g/L. Intervention Patients will be randomly assigned to either a liberal (threshold: Hb ≤100 g/L) or a restrictive transfusion strategy (threshold: Hb ≤80 g/L). Outcome Primary: Centre randomisation rate over the study period. Secondary: (1) transfusion threshold adherence; (2) study RBC transfusion protocol adherence; and (3) outcome assessment including vital status at hospital discharge, modified Rankin Score at 6 and 12 months and Functional Independence Measure and EuroQOL Quality of Life Scale scores at 12 months. Outcome measures will be reported in aggregate.

ETHICS AND DISSEMINATION:

The study protocol has been approved by the host centre (OHSN-REB 20150433-01H). This study will determine the feasibility of conducting the large pragmatic RCT comparing 2 RBC transfusion strategies examining the effect of a liberal strategy on 12-month outcome following aSAH.

TRIAL REGISTRATION NUMBER:

NCT02483351; Pre-results.

• Authors: Shane W English, D Fergusson, M Chassé, A F Turgeon, F Lauzier, D Griesdale, A Algird, A Kramer, A Tinmouth, C Lum, J Sinclair, S Marshall, D Dowlatshahi, A Boutin, G Pagliarello, L A McIntyre, Canadian Critical Care Trials Group
• Journal: BMJ open (BMJ Open) Vol. 6 Issue 12 Pg. e012623 (12 07 2016) ISSN: 2044-6055 [Electronic] England
• PMID: 27927658 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Topics

• Anemia (mortality)
• Clinical Protocols
• Critical Care
• Disability Evaluation
• Endovascular Procedures (methods, mortality)
• Erythrocyte Transfusion (methods, mortality)
• Feasibility Studies
• Female
• Humans
• Male
• North America (epidemiology)
• Outcome Assessment, Health Care
• Pilot Projects
• Quality of Life
• Risk Factors
• Subarachnoid Hemorrhage (mortality, physiopathology, therapy)
• Treatment Outcome