Subarachnoid Hemorrhage International Trialists data repository (SAHIT).

The outcome of patients with aneurysmal subarachnoid hemorrhage (SAH) has improved slowly over the past 25 years. This improvement may be due to early aneurysm repair by endovascular or open means, use of nimodipine, and better critical care management. Despite this improvement, mortality remains at about 40%, and many survivors have permanent neurologic, cognitive, and neuropsychologic deficits. Randomized clinical trials have tested pharmacologic therapies, but few have been successful. There are numerous explanations for the failure of these trials, including ineffective interventions, inadequate sample size, treatment side effects, and insensitive or inappropriate outcome measures. Outcome often is evaluated on a good-bad dichotomous scale that was developed for traumatic brain injury 40 years ago. To address these issues, we established the Subarachnoid Hemorrhage International Trialists (SAHIT) data repository. The primary aim of the SAHIT data repository is to provide a unique resource for prognostic analysis and for studies aimed at optimizing the design and analysis of phase III trials in aneurysmal SAH. With this aim in mind, we convened a multinational investigator meeting to explore merging individual patient data from multiple clinical trials and observational databases of patients with SAH and to create an agreement under which such a group of investigators could submit data and collaborate. We welcome collaboration with other investigators.

[1]  S. Mayer,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 , 2008, Stroke.

[2]  V. Feigin,et al.  Calcium antagonists for aneurysmal subarachnoid haemorrhage. , 2007, The Cochrane database of systematic reviews.

[3]  A. Molyneux International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial , 2002, The Lancet.

[4]  Foss Mv MANAGEMENT OF VIRUS HEPATITIS. , 1964 .

[5]  Hester F. Lingsma,et al.  Re-orientation of clinical research in traumatic brain injury: report of an international workshop on comparative effectiveness research. , 2012, Journal of neurotrauma.

[6]  J. Holmes,et al.  Lifetime cost of stroke in the United States. , 1996, Stroke.

[7]  M. Tobin Counterpoint: evidence-based medicine lacks a sound scientific base. , 2008, Chest.

[8]  Henry L. Lew,et al.  Standardizing data collection in traumatic brain injury. , 2011, Journal of neurotrauma.

[9]  R. Macdonald,et al.  Effect of pharmaceutical treatment on vasospasm, delayed cerebral ischemia, and clinical outcome in patients with aneurysmal subarachnoid hemorrhage: A systematic review and meta-analysis , 2011, Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism.

[10]  S. Pocock,et al.  Can We Improve the Statistical Analysis of Stroke Trials?: Statistical Reanalysis of Functional Outcomes in Stroke Trials , 2007, Stroke.

[11]  S. Mayer,et al.  Clazosentan, an endothelin receptor antagonist, in patients with aneurysmal subarachnoid haemorrhage undergoing surgical clipping: a randomised, double-blind, placebo-controlled phase 3 trial (CONSCIOUS-2) , 2011, The Lancet Neurology.

[12]  A. Algra,et al.  Incidence of subarachnoid hemorrhage: role of region, year, and rate of computed tomography: a meta-analysis. , 1996, Stroke.

[13]  P. Rothwell,et al.  Time trends in outcome of subarachnoid hemorrhage , 2010, Neurology.

[14]  W. Poon,et al.  Health-Related Quality of Life After Aneurysmal Subarachnoid Hemorrhage: Profile and Clinical Factors , 2011, Neurosurgery.

[15]  S. Mayer,et al.  Sample Size Estimates for Clinical Trials of Vasospasm in Subarachnoid Hemorrhage , 2009, Stroke.

[16]  H. Adams,et al.  Intracranial aneurysms and subarachnoid hemorrhage. , 1980, Journal of the Iowa Medical Society.

[17]  G. Murray,et al.  Effect of oral nimodipine on cerebral infarction and outcome after subarachnoid haemorrhage: British aneurysm nimodipine trial. , 1989, BMJ.

[18]  A. Schechter,et al.  Randomization in clinical trials of titrated therapies: Unintended consequences of using fixed treatment protocols* , 2007, Critical care medicine.

[19]  J. Vincent We should abandon randomized controlled trials in the intensive care unit , 2010, Critical care medicine.

[20]  T. Schweizer,et al.  Cognitive and Functional Outcome After Aneurysmal Subarachnoid Hemorrhage , 2010, Stroke.

[21]  J. Vincent,et al.  Multicenter, randomized, controlled trials evaluating mortality in intensive care: Doomed to fail? , 2008, Critical care medicine.

[22]  Jan Claassen,et al.  Prediction of symptomatic vasospasm after subarachnoid hemorrhage: the modified fisher scale. , 2006, Neurosurgery.

[23]  B. Jennett,et al.  ASSESSMENT OF OUTCOME AFTER SEVERE BRAIN DAMAGE A Practical Scale , 1975, The Lancet.

[24]  R. Macdonald,et al.  Lower incidence of cerebral infarction correlates with improved functional outcome after aneurysmal subarachnoid hemorrhage , 2011, Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism.

[25]  J. Saver Novel End Point Analytic Techniques and Interpreting Shifts Across the Entire Range of Outcome Scales in Acute Stroke Trials , 2007, Stroke.

[26]  A. Kramer Statins in the management of aneurysmal subarachnoid hemorrhage: an overview of animal research, observational studies, randomized controlled trials and meta-analyses. , 2011, Acta neurochirurgica. Supplement.

[27]  Ewout W Steyerberg,et al.  Prognosis and clinical trial design in traumatic brain injury: the IMPACT study. , 2007, Journal of neurotrauma.

[28]  Ale Algra,et al.  Changes in case fatality of aneurysmal subarachnoid haemorrhage over time, according to age, sex, and region: a meta-analysis , 2009, The Lancet Neurology.

[29]  A. Algra,et al.  Study Design and Outcome Measures in Studies on Aneurysmal Subarachnoid Hemorrhage , 2002, Stroke.