title: SAHIT Investigators--on the outcome of some subarachnoid hemorrhage clinical trials.
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.
authors: St. Michael's Hospital, University of Toronto, Toronto, ON, Canada, MacdonaldLo@smh.ca.
authors: R Loch
authors: RL
authors: Macdonald
authors: Blessing
authors: B
authors: Jaja
authors: Michael D
authors: MD
authors: Cusimano
authors: Nima
authors: N
authors: Etminan
authors: Daniel
authors: D
authors: Hanggi
authors: David
authors: D
authors: Hasan
authors: Don
authors: D
authors: Ilodigwe
authors: Hector
authors: H
authors: Lantigua
authors: Peter
authors: P
authors: Le Roux
authors: Benjamin
authors: B
authors: Lo
authors: Ada
authors: A
authors: Louffat-Olivares
authors: Stephan
authors: S
authors: Mayer
authors: Andrew
authors: A
authors: Molyneux
authors: Audrey
authors: A
authors: Quinn
authors: Tom A
authors: TA
authors: Schweizer
authors: Thomas
authors: T
authors: Schenk
authors: Julian
authors: J
authors: Spears
authors: Michael
authors: M
authors: Todd
authors: James
authors: J
authors: Torner
authors: Mervyn D I
authors: MD
authors: Vergouwen
authors: George K C
authors: GK
authors: Wong
authors: Jeff
authors: J
authors: Singh
mesh_terms: D000975:Antioxidants / Q000627:therapeutic use; D020520:Brain Infarction / Q000517:prevention & control; D002121:Calcium Channel Blockers / Q000627:therapeutic use; D003422:Critical Care; D004146:Dioxanes / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D002532:Intracranial Aneurysm / Q000188:drug therapy*; D017616:Magnesium Compounds / Q000627:therapeutic use; D018696:Neuroprotective Agents / Q000627:therapeutic use; D009529:Nicardipine / Q000627:therapeutic use; D009553:Nimodipine / Q000627:therapeutic use; D010818:Practice Patterns, Physicians'; D011281:Pregnatrienes / Q000627:therapeutic use; D011725:Pyridines / Q000627:therapeutic use; D011743:Pyrimidines / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D016879:Salvage Therapy / Q000379:methods; D018401:Sample Size; D013345:Subarachnoid Hemorrhage / Q000188:drug therapy*; D013449:Sulfonamides / Q000627:therapeutic use; D013777:Tetrazoles / Q000627:therapeutic use; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000627:therapeutic use; D020301:Vasospasm, Intracranial / Q000517:prevention & control
chemical_list: D000975:Antioxidants; D002121:Calcium Channel Blockers; D004146:Dioxanes; D017616:Magnesium Compounds; D018696:Neuroprotective Agents; D011281:Pregnatrienes; D011725:Pyridines; D011743:Pyrimidines; D013449:Sulfonamides; D013777:Tetrazoles; D014665:Vasodilator Agents; C074965:U 74389F; C109641:clazosentan; D009553:Nimodipine; D009529:Nicardipine