Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial

Summary

To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage.

Timeline

Start

2024-05-27

Primary completion

2026-05

Completion

2026-05

Publications

• Background Wartenberg KE, Schmidt JM, Claassen J, Temes RE, Frontera JA, Ostapkovich N, Parra A, Connolly ES, Mayer SA. Impact of medical complications on outcome after subarachnoid hemorrhage. Crit Care Med. 2006 Mar;34(3):617-23; quiz 624. doi: 10.1097/01.ccm.0000201903.46435.35.
• Results Al-Khindi T, Macdonald RL, Schweizer TA. Cognitive and functional outcome after aneurysmal subarachnoid hemorrhage. Stroke. 2010 Aug;41(8):e519-36. doi: 10.1161/STROKEAHA.110.581975. Epub 2010 Jul 1.
• Results Vergouwen MD; Participants in the International Multi-Disciplinary Consensus Conference on the Critical Care Management of Subarachnoid Hemorrhage. Vasospasm versus delayed cerebral ischemia as an outcome event in clinical trials and observational studies. Neurocrit Care. 2011 Sep;15(2):308-11. doi: 10.1007/s12028-011-9586-8.
• Results Macdonald RL, Hunsche E, Schuler R, Wlodarczyk J, Mayer SA. Quality of life and healthcare resource use associated with angiographic vasospasm after aneurysmal subarachnoid hemorrhage. Stroke. 2012 Apr;43(4):1082-8. doi: 10.1161/STROKEAHA.111.634071. Epub 2012 Feb 9.
• Results Springer MV, Schmidt JM, Wartenberg KE, Frontera JA, Badjatia N, Mayer SA. Predictors of global cognitive impairment 1 year after subarachnoid hemorrhage. Neurosurgery. 2009 Dec;65(6):1043-50; discussion 1050-1. doi: 10.1227/01.NEU.0000359317.15269.20.
• Results Pegoli M, Mandrekar J, Rabinstein AA, Lanzino G. Predictors of excellent functional outcome in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2015 Feb;122(2):414-8. doi: 10.3171/2014.10.JNS14290. Epub 2014 Dec 12.
• Results Frontera JA, Fernandez A, Schmidt JM, Claassen J, Wartenberg KE, Badjatia N, Connolly ES, Mayer SA. Defining vasospasm after subarachnoid hemorrhage: what is the most clinically relevant definition? Stroke. 2009 Jun;40(6):1963-8. doi: 10.1161/STROKEAHA.108.544700. Epub 2009 Apr 9.
• Results Vergouwen MD, Vermeulen M, van Gijn J, Rinkel GJ, Wijdicks EF, Muizelaar JP, Mendelow AD, Juvela S, Yonas H, Terbrugge KG, Macdonald RL, Diringer MN, Broderick JP, Dreier JP, Roos YB. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group. Stroke. 2010 Oct;41(10):2391-5. doi: 10.1161/STROKEAHA.110.589275. Epub 2010 Aug 26.
• Results Grossen AA, Ernst GL, Bauer AM. Update on intrathecal management of cerebral vasospasm: a systematic review and meta-analysis. Neurosurg Focus. 2022 Mar;52(3):E10. doi: 10.3171/2021.12.FOCUS21629.
• Results Fisher CM, Kistler JP, Davis JM. Relation of cerebral vasospasm to subarachnoid hemorrhage visualized by computerized tomographic scanning. Neurosurgery. 1980 Jan;6(1):1-9. doi: 10.1227/00006123-198001000-00001.
• Results Reilly C, Amidei C, Tolentino J, Jahromi BS, Macdonald RL. Clot volume and clearance rate as independent predictors of vasospasm after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2004 Aug;101(2):255-61. doi: 10.3171/jns.2004.101.2.0255.
• Results Vorkapic P, Bevan JA, Bevan RD. Longitudinal in vivo and in vitro time-course study of chronic cerebrovasospasm in the rabbit basilar artery. Neurosurg Rev. 1991;14(3):215-9. doi: 10.1007/BF00310660.
• Results Al-Mufti F, Amuluru K, Damodara N, El-Ghanem M, Nuoman R, Kamal N, Al-Marsoummi S, Morris NA, Dangayach NS, Mayer SA. Novel management strategies for medically-refractory vasospasm following aneurysmal subarachnoid hemorrhage. J Neurol Sci. 2018 Jul 15;390:44-51. doi: 10.1016/j.jns.2018.02.039. Epub 2018 Feb 23.
• Results Murayama Y, Malisch T, Guglielmi G, Mawad ME, Vinuela F, Duckwiler GR, Gobin YP, Klucznick RP, Martin NA, Frazee J. Incidence of cerebral vasospasm after endovascular treatment of acutely ruptured aneurysms: report on 69 cases. J Neurosurg. 1997 Dec;87(6):830-5. doi: 10.3171/jns.1997.87.6.0830.
• Results Yalamanchili K, Rosenwasser RH, Thomas JE, Liebman K, McMorrow C, Gannon P. Frequency of cerebral vasospasm in patients treated with endovascular occlusion of intracranial aneurysms. AJNR Am J Neuroradiol. 1998 Mar;19(3):553-8.
• Results Charpentier C, Audibert G, Guillemin F, Civit T, Ducrocq X, Bracard S, Hepner H, Picard L, Laxenaire MC. Multivariate analysis of predictors of cerebral vasospasm occurrence after aneurysmal subarachnoid hemorrhage. Stroke. 1999 Jul;30(7):1402-8. doi: 10.1161/01.str.30.7.1402.
• Results Rumalla K, Lin M, Ding L, Gaddis M, Giannotta SL, Attenello FJ, Mack WJ. Risk Factors for Cerebral Vasospasm in Aneurysmal Subarachnoid Hemorrhage: A Population-Based Study of 8346 Patients. World Neurosurg. 2021 Jan;145:e233-e241. doi: 10.1016/j.wneu.2020.10.008. Epub 2020 Oct 10.
• Results Pelz DM, Lownie SP, Mayich MS, Pandey SK, Sharma M. Interventional Neuroradiology: A Review. Can J Neurol Sci. 2021 Mar;48(2):172-188. doi: 10.1017/cjn.2020.153. Epub 2020 Jul 16.
• Results Foreman B. The Pathophysiology of Delayed Cerebral Ischemia. J Clin Neurophysiol. 2016 Jun;33(3):174-82. doi: 10.1097/WNP.0000000000000273.
• Results Abruzzo T, Moran C, Blackham KA, Eskey CJ, Lev R, Meyers P, Narayanan S, Prestigiacomo CJ. Invasive interventional management of post-hemorrhagic cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage. J Neurointerv Surg. 2012 May;4(3):169-77. doi: 10.1136/neurintsurg-2011-010248. Epub 2012 Feb 28.
• Results Dorsch N. A clinical review of cerebral vasospasm and delayed ischaemia following aneurysm rupture. Acta Neurochir Suppl. 2011;110(Pt 1):5-6. doi: 10.1007/978-3-7091-0353-1_1.
• Results Dorhout Mees SM, Kerr RS, Rinkel GJ, Algra A, Molyneux AJ. Occurrence and impact of delayed cerebral ischemia after coiling and after clipping in the International Subarachnoid Aneurysm Trial (ISAT). J Neurol. 2012 Apr;259(4):679-83. doi: 10.1007/s00415-011-6243-2. Epub 2011 Sep 24.
• Results Rosengart AJ, Huo JD, Tolentino J, Novakovic RL, Frank JI, Goldenberg FD, Macdonald RL. Outcome in patients with subarachnoid hemorrhage treated with antiepileptic drugs. J Neurosurg. 2007 Aug;107(2):253-60. doi: 10.3171/JNS-07/08/0253.
• Results Macdonald RL, Rosengart A, Huo D, Karrison T. Factors associated with the development of vasospasm after planned surgical treatment of aneurysmal subarachnoid hemorrhage. J Neurosurg. 2003 Oct;99(4):644-52. doi: 10.3171/jns.2003.99.4.0644.
• Results Crowley RW, Medel R, Dumont AS, Ilodigwe D, Kassell NF, Mayer SA, Ruefenacht D, Schmiedek P, Weidauer S, Pasqualin A, Macdonald RL. Angiographic vasospasm is strongly correlated with cerebral infarction after subarachnoid hemorrhage. Stroke. 2011 Apr;42(4):919-23. doi: 10.1161/STROKEAHA.110.597005. Epub 2011 Feb 24.
• Results Suzuki S, Suzuki M, Iwabuchi T, Kamata Y. Role of multiple cerebral microthrombosis in symptomatic cerebral vasospasm: with a case report. Neurosurgery. 1983 Aug;13(2):199-203. doi: 10.1227/00006123-198308000-00018.
• Results Romano JG, Forteza AM, Concha M, Koch S, Heros RC, Morcos JJ, Babikian VL. Detection of microemboli by transcranial Doppler ultrasonography in aneurysmal subarachnoid hemorrhage. Neurosurgery. 2002 May;50(5):1026-30; discussion 1030-1. doi: 10.1097/00006123-200205000-00016.
• Results Romano JG, Rabinstein AA, Arheart KL, Nathan S, Campo-Bustillo I, Koch S, Forteza AM. Microemboli in aneurysmal subarachnoid hemorrhage. J Neuroimaging. 2008 Oct;18(4):396-401. doi: 10.1111/j.1552-6569.2007.00215.x. Epub 2008 May 19.
• Results Etminan N, Vergouwen MD, Ilodigwe D, Macdonald RL. Effect of pharmaceutical treatment on vasospasm, delayed cerebral ischemia, and clinical outcome in patients with aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. J Cereb Blood Flow Metab. 2011 Jun;31(6):1443-51. doi: 10.1038/jcbfm.2011.7. Epub 2011 Feb 2.
• Results Macdonald RL. Delayed neurological deterioration after subarachnoid haemorrhage. Nat Rev Neurol. 2014 Jan;10(1):44-58. doi: 10.1038/nrneurol.2013.246. Epub 2013 Dec 10.
• Results Macdonald RL, Cusimano MD, Etminan N, Hanggi D, Hasan D, Ilodigwe D, Jaja B, Lantigua H, Le Roux P, Lo B, Louffat-Olivares A, Mayer S, Molyneux A, Quinn A, Schweizer TA, Schenk T, Spears J, Todd M, Torner J, Vergouwen MD, Wong GK; SAHIT Collaboration. Subarachnoid Hemorrhage International Trialists data repository (SAHIT). World Neurosurg. 2013 Mar-Apr;79(3-4):418-22. doi: 10.1016/j.wneu.2013.01.006. Epub 2013 Jan 4.
• Results Ganesh A, Luengo-Fernandez R, Wharton RM, Rothwell PM; Oxford Vascular Study. Ordinal vs dichotomous analyses of modified Rankin Scale, 5-year outcome, and cost of stroke. Neurology. 2018 Nov 20;91(21):e1951-e1960. doi: 10.1212/WNL.0000000000006554. Epub 2018 Oct 19.
• Results Rosenberg N, Lazzaro MA, Lopes DK, Prabhakaran S. High-dose intra-arterial nicardipine results in hypotension following vasospasm treatment in subarachnoid hemorrhage. Neurocrit Care. 2011 Dec;15(3):400-4. doi: 10.1007/s12028-011-9537-4.
• Results Akbik F, Waddel H, Jaja BNR, Macdonald RL, Moore R, Samuels OB, Sadan O. Nicardipine Prolonged Release Implants for Prevention of Delayed Cerebral Ischemia after Aneurysmal Subarachnoid Hemorrhage: A Meta-Analysis. J Stroke Cerebrovasc Dis. 2021 Oct;30(10):106020. doi: 10.1016/j.jstrokecerebrovasdis.2021.106020. Epub 2021 Aug 5.
• Results Barth M, Capelle HH, Weidauer S, Weiss C, Munch E, Thome C, Luecke T, Schmiedek P, Kasuya H, Vajkoczy P. Effect of nicardipine prolonged-release implants on cerebral vasospasm and clinical outcome after severe aneurysmal subarachnoid hemorrhage: a prospective, randomized, double-blind phase IIa study. Stroke. 2007 Feb;38(2):330-6. doi: 10.1161/01.STR.0000254601.74596.0f. Epub 2006 Dec 21.
• Results Yokoya S, Hino A, Goto Y, Oka H. Complete relief of vasospasm - Effect of nicardipine coating during direct clipping for the patient with symptomatic vasospasm of subarachnoid hemorrhage. Surg Neurol Int. 2020 Nov 18;11:394. doi: 10.25259/SNI_640_2020. eCollection 2020.
• Results Dayyani M, Sadeghirad B, Grotta JC, Zabihyan S, Ahmadvand S, Wang Y, Guyatt GH, Amin-Hanjani S. Prophylactic Therapies for Morbidity and Mortality After Aneurysmal Subarachnoid Hemorrhage: A Systematic Review and Network Meta-Analysis of Randomized Trials. Stroke. 2022 Jun;53(6):1993-2005. doi: 10.1161/STROKEAHA.121.035699. Epub 2022 Mar 31.
• Results Weyer GW, Nolan CP, Macdonald RL. Evidence-based cerebral vasospasm management. Neurosurg Focus. 2006 Sep 15;21(3):E8. doi: 10.3171/foc.2006.21.3.8.
• Results Sadan O, Waddel H, Moore R, Feng C, Mei Y, Pearce D, Kraft J, Pimentel C, Mathew S, Akbik F, Ameli P, Taylor A, Danyluk L, Martin KS, Garner K, Kolenda J, Pujari A, Asbury W, Jaja BNR, Macdonald RL, Cawley CM, Barrow DL, Samuels O. Does intrathecal nicardipine for cerebral vasospasm following subarachnoid hemorrhage correlate with reduced delayed cerebral ischemia? A retrospective propensity score-based analysis. J Neurosurg. 2021 Jun 4;136(1):115-124. doi: 10.3171/2020.12.JNS203673. Print 2022 Jan 1.

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Indications