Outcome of patients with aneurysmal subarachnoid hemorrhage (SAH) has improved over the last decades. Yet, case fatality remains nearly 40 % and survivors often have permanent neurological, cognitive and/or behavioural sequelae. Other than nimodipine drug or clinical trials have not consistently improved outcome. We formed a collaboration of SAH investigators to create a resource for prognostic analysis and for studies aimed at optimizing the design and analysis of phase 3 trials in aneurysmal SAH. We identified investigators with data from randomized, clinical trials of patients with aneurysmal SAH or prospectively collected single- or multicentre databases of aneurysmal SAH patients. Data are being collected and proposals to use the data and to design future phase 3 clinical trials are being discussed. This paper reviews some issues discussed at the first meeting of the SAH international trialists (SAHIT) repository meeting. Investigators contributed or have agreed to contribute data from several phase 3 trials including the tirilazad trials, intraoperative hypothermia for aneurysmal SAH trial, nicardipine clinical trials, international subarachnoid aneurysm trial, intravenous magnesium sulphate for aneurysmal SAH, magnesium for aneurysmal SAH and from prospectively-collected data from four institutions. The number of patients should reach 15,000. Some industry investigators refused to provide data and others reported that their institutional research ethics boards would not permit even deidentified or anonymized data to be included. Others reported conflict of interest that prevented them from submitting data. The problems with merging data were related to lack of common definitions and coding of variables, differences in outcome scales used, and times of assessment. Some questions for investigation that arose are discussed. SAHIT demonstrates the possibility of SAH investigators to contribute data for collaborative research. The problems are similar to those already documented in other similar collaborative efforts such as in head injury research. We encourage clinical trial and registry investigators to contact us and participate in SAHIT. Key issues moving forward will be to use common definitions (common data elements), outcomes analysis, and to prioritize research questions, among others.
Bibliographical noteFunding Information:
Funded by a grant from the Canadian Institutes
Disclosures Michael D. Cusimano receives grant support from the Canadian Institutes for Health Research. Nima Etminan receives grant support from Physicians Services Incorporated Foundation. David Hasan receives grant funding from National Institutes of Health and Brain Aneurysm Foundation. Peter Le Roux receives research funding from the National Institutes of Health and Integra and is a consultant for Codman, Integra and Edge Therapeutics. R. Loch Macdonald receives grant funding from the Canadian Institutes for Health Research, Heart and Stroke Foundation of Canada, Canadian Stroke Network, Brain Aneurysm Foundation and Physicians Services Incorporated Foundation. He is a consultant for Actelion Pharmaceuticals, Ltd. and Chief Scientific Officer of Edge Therapeutics, Inc. Stephan Mayer is a consultant for Actelion Pharmaceuticals, Ltd. Andrew Molyneux is a consultant for Micrus Endovascular and receives grant support from the Medical Research Council UK and Cerecyte Coil Trial. Tom A. Schweizer receives grant support from the Heart and Stroke Foundation of Canada, the Canadian Institutes of Health Research and the Ontario Ministry of Research and Innovation. Michael Todd receives grant support from the National Institutes of Health. James Torner receives grant support from the National Institutes of Health. Mervyn D.I. Vergouwen receives grant support from the Netherlands Thrombosis Foundation and Netherlands Heart Foundation. George K.C. Wong receives grant support from the Hong Kong Food and Health Bureau and the Hong Kong University Grant Committee.
Copyright 2014 Elsevier B.V., All rights reserved.
- Clinical trial
- Subarachnoid hemorrhage