Journal article
SAHIT Investigators--on the outcome of some subarachnoid hemorrhage clinical trials
Translational stroke research, Vol.4(3), pp.286-296
06/2013
DOI: 10.1007/s12975-012-0242-1
PMID: 24323299
Abstract
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.
Details
- Title: Subtitle
- SAHIT Investigators--on the outcome of some subarachnoid hemorrhage clinical trials
- Creators
- R Loch Macdonald - St. Michael's Hospital, University of Toronto, Toronto, ON, Canada, MacdonaldLo@smh.caBlessing JajaMichael D CusimanoNima EtminanDaniel HanggiDavid HasanDon IlodigweHector LantiguaPeter Le RouxBenjamin LoAda Louffat-OlivaresStephan MayerAndrew MolyneuxAudrey QuinnTom A SchweizerThomas SchenkJulian SpearsMichael ToddJames TornerMervyn D I VergouwenGeorge K C WongJeff SinghSAHIT Collaboration
- Resource Type
- Journal article
- Publication Details
- Translational stroke research, Vol.4(3), pp.286-296
- DOI
- 10.1007/s12975-012-0242-1
- PMID
- 24323299
- NLM abbreviation
- Transl Stroke Res
- ISSN
- 1868-601X
- eISSN
- 1868-601X
- Publisher
- United States
- Grant note
- Canadian Institutes of Health Research
- Language
- English
- Date published
- 06/2013
- Academic Unit
- Roy J. Carver Department of Biomedical Engineering; Epidemiology; Surgery; Anesthesia; Injury Prevention Research Center; Neurosurgery; Otolaryngology
- Record Identifier
- 9983995040602771
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