gms | German Medical Science

57th Annual Meeting of the German Society of Neurosurgery
Joint Meeting with the Japanese Neurosurgical Society

German Society of Neurosurgery (DGNC)

11 - 14 May, Essen

Article

Send article

Nicardipine prolonged-release pellets reduce the incidence of cerebral vasospasm following aneurysmal subarachnoid hemorrhage – a prospective, monocentric, double blind study

Nicardipin prolonged-release pellets verringern die Inzidenz des zerebralen Vasospasmus nach aneurysmatischer Subarachnoidalblutung – eine monozentrische, randomisierte, Doppelblind-Studie

Meeting Abstract

Search Medline for

  • corresponding author M. Barth - Neurochirurgische Klinik, Mannheim
  • H.-H. Capelle - Neurochirurgische Klinik, Mannheim
  • S. Weidauer - Neuroradiologie, Frankfurt am Main
  • C. Thomé - Neurochirurgische Klinik, Mannheim
  • P. Schmiedek - Neurochirurgische Klinik, Mannheim
  • H. Kasuya - Department of Neurosurgery, Tokyo/Japan
  • P. Vajkoczy - Neurochirurgische Klinik, Mannheim

Deutsche Gesellschaft für Neurochirurgie. Japanische Gesellschaft für Neurochirurgie. 57. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie e.V. (DGNC), Joint Meeting mit der Japanischen Gesellschaft für Neurochirurgie. Essen, 11.-14.05.2006. Düsseldorf, Köln: German Medical Science; 2006. DocSO.06.06

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/dgnc2006/06dgnc196.shtml

Published: May 8, 2006

© 2006 Barth et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

Text

Objective: This trial investigated the efficacy of Nicardipine prolonged-release implants, placed into the basal cisterns at the time of aneurysm clipping, in patients with aneurysmal subarachnoid hemorrhage (SAH).

Methods: 32 patients were included with severe SAH (H&H grade 3-4, Fisher grade 3). All patients underwent clipping and were randomized into two groups: immediately after clipping of the aneurysm 16 patients received Nicardipine prolonged-release pellets (n=10; 4 mg of Nicardipine per pellet) located in direct contact to the exposed proximal blood vessels (ICA, A1, M1); in 16 control patients the basal cisterns were opened and washed out only, without leaving implants. Investigators and an external neuroradiologist were blinded to the randomization. Degree of vasospasm was measured in relative differences [%] of vessel diameters of the follow-up angiogram on day 8±1 after SAH compared to the baseline angiogram in different basal vessel segments. Primary endpoints were incidence of angiographic vasospasm (<33% constriction) on day 8±1 after SAH and new territorial infarcts on CT.

Results: 29 patients (14 verum, 15 control) were included in the Intent-To-Treat population. Implantation of Nicardipine prolonged-release pellets yielded a significant reduction in the incidence of angiographic vasospasm: while 75% of the control patients demonstrated spasm of the basal arteries, only 7% did so in the pellet group. The incidence of new territorial infarcts in the control and pellet groups was 47% and 7%, respectively. There was no adverse event pattern indicating a toxicity of the implants.

Conclusions: This study indicates that Nicardipine prolonged-release implants reduce the incidence of cerebral vasospasm and infarcts following severe aneurysmal SAH.