naa a22 4500 510775985 CHVBK 20180411083230.0 cr unu---uuuuu 180411e20130601xx s 000 0 eng 10.1007/s12975-012-0242-1 doi (NATIONALLICENCE)springer-10.1007/s12975-012-0242-1 SAHIT Investigators—on the Outcome of Some Subarachnoid Hemorrhage Clinical Trials [Elektronische Daten] [R. Macdonald, Blessing Jaja, Michael Cusimano, Nima Etminan, Daniel Hanggi, David Hasan, Don Ilodigwe, Hector Lantigua, Peter Le Roux, Benjamin Lo, Ada Louffat-Olivares, Stephan Mayer, Andrew Molyneux, Audrey Quinn, Tom Schweizer, Thomas Schenk, Julian Spears, Michael Todd, James Torner, Mervyn Vergouwen, George Wong, Jeff Singh] 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. Springer Science+Business Media New York, 2012 Clinical trial nationallicence Outcome nationallicence Subarachnoid hemorrhage nationallicence Macdonald R. St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut Jaja Blessing St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut Cusimano Michael St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut Etminan Nima Department of Neurosurgery, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany aut Hanggi Daniel Department of Neurosurgery, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany aut Hasan David University of Iowa, Iowa, IA, USA aut Ilodigwe Don St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut Lantigua Hector Columbia University, New York, NY, USA aut Le Roux Peter University of Pennsylvania, Philadelphia, PA, USA aut Lo Benjamin St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut Louffat-Olivares Ada St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut Mayer Stephan Columbia University, New York, NY, USA aut Molyneux Andrew Oxford University, Oxford, UK aut Quinn Audrey The General Infirmary, Leeds, UK aut Schweizer Tom St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut Schenk Thomas King's College London, London, UK aut Spears Julian St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut Todd Michael University of Iowa, Iowa, IA, USA aut Torner James University of Iowa, Iowa, IA, USA aut Vergouwen Mervyn University Medical Center Utrecht, Utrecht, The Netherlands aut Wong George Chinese University of Hong Kong, Ma Liu Shui, New Territories, Hong Kong aut Singh Jeff University Health Network, University of Toronto, Toronto, ON, Canada aut Translational Stroke Research Springer-Verlag 4/3(2013-06-01), 286-296 1868-4483 4:3<286 2013 4 12975 https://doi.org/10.1007/s12975-012-0242-1 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s12975-012-0242-1 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Macdonald R. St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut NATIONALLICENCE 700 1- Jaja Blessing St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut NATIONALLICENCE 700 1- Cusimano Michael St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut NATIONALLICENCE 700 1- Etminan Nima Department of Neurosurgery, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany aut NATIONALLICENCE 700 1- Hanggi Daniel Department of Neurosurgery, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany aut NATIONALLICENCE 700 1- Hasan David University of Iowa, Iowa, IA, USA aut NATIONALLICENCE 700 1- Ilodigwe Don St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut NATIONALLICENCE 700 1- Lantigua Hector Columbia University, New York, NY, USA aut NATIONALLICENCE 700 1- Le Roux Peter University of Pennsylvania, Philadelphia, PA, USA aut NATIONALLICENCE 700 1- Lo Benjamin St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut NATIONALLICENCE 700 1- Louffat-Olivares Ada St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut NATIONALLICENCE 700 1- Mayer Stephan Columbia University, New York, NY, USA aut NATIONALLICENCE 700 1- Molyneux Andrew Oxford University, Oxford, UK aut NATIONALLICENCE 700 1- Quinn Audrey The General Infirmary, Leeds, UK aut NATIONALLICENCE 700 1- Schweizer Tom St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut NATIONALLICENCE 700 1- Schenk Thomas King's College London, London, UK aut NATIONALLICENCE 700 1- Spears Julian St. Michael's Hospital, University of Toronto, Toronto, ON, Canada aut NATIONALLICENCE 700 1- Todd Michael University of Iowa, Iowa, IA, USA aut NATIONALLICENCE 700 1- Torner James University of Iowa, Iowa, IA, USA aut NATIONALLICENCE 700 1- Vergouwen Mervyn University Medical Center Utrecht, Utrecht, The Netherlands aut NATIONALLICENCE 700 1- Wong George Chinese University of Hong Kong, Ma Liu Shui, New Territories, Hong Kong aut NATIONALLICENCE 700 1- Singh Jeff University Health Network, University of Toronto, Toronto, ON, Canada aut NATIONALLICENCE 773 0- Translational Stroke Research Springer-Verlag 4/3(2013-06-01), 286-296 1868-4483 4:3<286 2013 4 12975 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer