NDLI: SAHIT Investigators—on the Outcome of Some Subarachnoid Hemorrhage Clinical Trials

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Translational Stroke Research : Volume 4, Issue 2, April 2013

Translational Stroke Research : Volume 4, Issue 1, February 2013

Translational Stroke Research : Volume 3

Translational Stroke Research : Volume 2

Translational Stroke Research : Volume 1

SAHIT Investigators—on the Outcome of Some Subarachnoid Hemorrhage Clinical Trials

Content Provider	Springer Nature Link
Author	Macdonald, R. Loch Jaja, Blessing Cusimano, Michael D. Etminan, Nima Hanggi, Daniel Hasan, David Ilodigwe, Don Lantigua, Hector Roux, Peter Lo, Benjamin Louffat Olivares, Ada Mayer, Stephan Molyneux, Andrew Quinn, Audrey Schweizer, Tom A. Schenk, Thomas Spears, Julian Todd, Michael Torner, James Vergouwen, Mervyn D. I. Wong, George K. C. Singh, Jeff
Copyright Year	2012
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.
Starting Page	286
Ending Page	296
Page Count	11
File Format	PDF
ISSN	18684483
Journal	Translational Stroke Research
Volume Number	4
Issue Number	3
e-ISSN	1868601X
Language	English
Publisher	Springer-Verlag
Publisher Date	2013-01-07
Publisher Place	New York
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Clinical trial Outcome Subarachnoid hemorrhage Neurosciences Neurology Cardiology Neurosurgery Vascular Surgery
Content Type	Text
Resource Type	Article
Subject	Cardiology and Cardiovascular Medicine Neuroscience Neurology (clinical)

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4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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SAHIT Investigators—on the Outcome of Some Subarachnoid Hemorrhage Clinical Trials

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