Affiliation: | 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
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Abstract: | 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. |