The Subarachnoid Hemorrhage International Trialists (SAHIT) Repository: Advancing Clinical Research in Subarachnoid Hemorrhage

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• 作者：Blessing N. R. Jaja (1)
  Daniel Attalla (1)
  R. Loch Macdonald (1)
  Tom A. Schweizer (1)
  Michael D. Cusimano (1)
  Nima Etminan (2)
  Daniel Hanggi (2)
  David Hasan (3)
  S. Claiborne Johnston (4)
  Peter Le Roux (5)
  Benjamin Lo (1)
  Ada Louffat-Olivares (1)
  Stephan Mayer (6)
  Andrew Molyneux (7)
  Adam Noble (8)
  Audrey Quinn (9)
  Thomas Schenk (10)
  Julian Spears (1)
  Jeffrey Singh (11)
  Michael Todd (3)
  James Torner (3)
  Ming Tseng (12)
  William van den Bergh (13)
  Mervyn D. I. Vergouwen (14)
  George K. C. Wong (15)
  
• 关键词：Subarachnoid hemorrhage ; Clinical trials ; Database ; Cerebrovascular disease ; Intracranial aneurysm ; Stroke
• 刊名：Neurocritical Care
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：21
• 期：3
• 页码：551-559
• 全文大小：549 KB
• 参考文献：1. Korja M, Silventoinen K, Laatikainen T, Jousilahti P, Salomaa V, Kaprio J. Cause-specific mortality of 1-year survivors of subarachnoid hemorrhage. Neurology. 2013;80:481-. CrossRef
  2. Al-Khindi T, Macdonald RL, Schweizer TA. Cognitive and functional outcome after aneurysmal subarachnoid hemorrhage. Stroke. 2010;41:519-6. CrossRef
  3. Nieuwkamp DJ, Setz LE, Algra A, Linn FH, de Rooij NK, Rinkel GJ. Changes in case fatality of aneurysmal subarachnoid haemorrhage over time, according to age, sex, and region: a meta-analysis. Lancet Neurol. 2009;8:635-2. CrossRef
  4. Lovelock CE, Rinkel GJE, Rothwell PM. Time trends in outcome of subarachnoid hemorrhage population-based study and systematic review. Neurology. 2010;74:1494-01. CrossRef
  5. Bederson JB, Connolly ES Jr, Batjer HH, et al. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a statement for healthcare professionals from a special writing group of the Stroke Council, American Heart Association. Stroke. 2009;40:994-025. CrossRef
  6. Pickard JD, Murray GD, Illingworth R, et al. Effect of oral nimodipine on cerebral infarction and outcome after subarachnoid haemorrhage: British aneurysm nimodipine trial. BMJ. 1989;298:636-2. CrossRef
  7. Molyneux A, Kerr R, Stratton I, et al. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial. Lancet. 2002;360:1267-4. CrossRef
  8. Macdonald RL, Jaja B, Cusimano MD, et al. SAHIT investigators-on the outcome of some subarachnoid hemorrhage clinical trials. Transl Stroke Res. 2013;4:286-6. CrossRef
  9. Macdonald RL, Cusimano MD, Etminan N, et al. Subarachnoid Hemorrhage International Trialists data repository (SAHIT). World Neurosurg. 2013;79:418-2. CrossRef
  10. Maas AI, Steyerberg EW, Marmarou A, et al. IMPACT recommendations for improving the design and analysis of clinical trials in moderate to severe traumatic brain injury. Neurotherapeutics. 2010;7:127-4. CrossRef
  11. Bath PM, Lees KR, Schellinger PD, et al. Statistical analysis of the primary outcome in acute stroke trials. Stroke. 2012;43:1171-. CrossRef
  12. van den Bergh WM, Algra A, van KF, et al. Magnesium sulfate in aneurysmal subarachnoid hemorrhage: a randomized controlled trial. Stroke. 2005;36:1011-. CrossRef
  13. Wong GKC, Poon WS, Chan MTV, et al. Intravenous magnesium sulphate for aneurysmal subarachnoid hemorrhage (IMASH) a randomized, double-blinded, placebo-controlled, multicenter phase III trial. Stroke. 2010;41:921-. CrossRef
  14. Macdonald RL, Kassell NF, Mayer S, et al. Clazosentan to overcome neurological ischemia and infarction occurring after subarachnoid hemorrhage (CONSCIOUS-1): randomized, double-blind, placebo-controlled phase 2 dose-finding trial. Stroke. 2008;39:3015-1. CrossRef
  15. Todd MM, Hindman BJ, Clarke WR, Torner JC. Mild intraoperative hypothermia during surgery for intracranial aneurysm. N Engl J Med. 2005;352:135-5. CrossRef
  16. Johnston SC, McDougall CG, Gholkar A. The MAPS tri
• 作者单位：Blessing N. R. Jaja (1)
  Daniel Attalla (1)
  R. Loch Macdonald (1)
  Tom A. Schweizer (1)
  Michael D. Cusimano (1)
  Nima Etminan (2)
  Daniel Hanggi (2)
  David Hasan (3)
  S. Claiborne Johnston (4)
  Peter Le Roux (5)
  Benjamin Lo (1)
  Ada Louffat-Olivares (1)
  Stephan Mayer (6)
  Andrew Molyneux (7)
  Adam Noble (8)
  Audrey Quinn (9)
  Thomas Schenk (10)
  Julian Spears (1)
  Jeffrey Singh (11)
  Michael Todd (3)
  James Torner (3)
  Ming Tseng (12)
  William van den Bergh (13)
  Mervyn D. I. Vergouwen (14)
  George K. C. Wong (15)
  
  1. Division of Neurosurgery, Department of Surgery, St. Michael’s Hospital, Labatt Family Centre of Excellence in Brain Injury and Trauma Research, Keenan Research Centre of the Li Ka Shing Knowledge Institute of St. Michael’s Hospital, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada
  2. Department of Neurosurgery, Medical Faculty Heinrich Heine University, Düsseldorf, Germany
  3. University of Iowa, Iowa City, IA, USA
  4. University of California San Francisco, San Francisco, CA, USA
  5. Jefferson University, Philadelphia, PA, USA
  6. Columbia University, New York, NY, USA
  7. Oxford University, Oxford, UK
  8. Kings College London, London, UK
  9. The General Infirmary, Leeds, UK
  10. Friedrich-Alexander University, Erlangen, Germany
  11. University of Toronto, University Health Network, Toronto, ON, Canada
  12. Medicines and Healthcare Products Regulatory Agency, London, UK
  13. University Medical Center Groningen, Groningen, The Netherlands
  14. University Medical Center Utrecht, Utrecht, The Netherlands
  15. Chinese University of Hong Kong, Hong Kong, China
  
• ISSN：1556-0961

文摘

Researchers and other stakeholders continue to express concern about the failure of randomized clinical trials (RCT) in subarachnoid hemorrhage (SAH) to show efficacy of new treatments. Pooled data may be particularly useful to generate hypotheses about causes of poor outcomes and reasons for failure of RCT in SAH, and strategies to improve them. Investigators conducting SAH research collaborated to share data with the intent to develop a large repository of pooled individual patient data for exploratory analysis and testing of new hypotheses relevant to improved trial design and analysis in SAH. This repository currently contains information on 11,443 SAH patients from 14 clinical databases, of which 9 are datasets of recent RCTs and 5 are datasets of prospective observational studies and hospital registries. Most patients were managed in the last 15?years. Data validation and quality checks have been conducted and are satisfactory. Data is available on demographic, clinical, neuroimaging, and laboratory results and various outcome measures. We have compiled the largest known dataset of patients with SAH. The SAHIT repository may be an important resource for advancing clinical research in SAH and will benefit from contributions of additional datasets.