Clinical trial NCT06329635 - References

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

Citation(s)

•   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
•   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
•   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.
•   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;39
•   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 prospec
•   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.
•   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
•   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
•   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/s00415-0
•   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.
•   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 F
•   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.
•   Foreman B
  The Pathophysiology of Delayed Cerebral Ischemia. J Clin Neurophysiol. 2016 Jun;33(3):174-82. doi: 10.1097/WNP.0000000000000273.
•   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.10
•   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
•   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.
•   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
  Sub
•   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
•   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.
•   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.
•   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)
•   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.
•   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.
•   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.
•   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: 10.1097/000061
•   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.
•   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.
•   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.
•   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.202
•   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 nicard
•   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.
•   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.
•   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 h
•   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
•   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.
•   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.
•   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.
•   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.
•   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. eC

Trial of Treatment of Vasospasm Associated With Aneurysmal Subarachnoid Hemorrhage With Intrathecal Injection of Nicardipine: a Multi-center, Prospective, Double-blinded, Randomized Controlled Trial

Details for clinical trial NCT06329635