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.
OBJECTIVE
The purpose of this study was to investigate the effect of nicardipine prolonged-release implants (NPRIs) on cerebral vasospasm and clinical outcome after severe subarachnoid hemorrhage.


METHODS
Thirty-two patients with severe subarachnoid hemorrhage and undergoing aneurysm clipping were included into this single center, randomized, double-blind trial. Sixteen patients received NPRIs implanted into the basal cisterns in direct contact to the exposed proximal blood vessels; in 16 control patients, the basal cisterns were opened and washed out only without leaving implants. Angiography was performed preoperatively and at day 8+/-1. Computed tomography imaging was analyzed for the incidence of territorial infarcts unrelated to surgery. Patient outcome was assessed using the modified Rankin and National Institute of Health Stroke scales.


RESULTS
The incidence of angiographic vasospasm in proximal vessel segments was significantly reduced after implantation of NPRIs (73% control versus 7% NPRIs). Significant differences occurred also for the majority of distal vessel segments. Computed tomography scans revealed a lower incidence of delayed ischemic lesions (47% control versus 14% NPRIs). The NPRI group demonstrated more favorable modified Rankin and National Institute of Health Stroke scales as well as a significantly lower incidence of deaths (38% control versus 6% NPRIs).


CONCLUSIONS
Implantation of NPRIs reduces the incidence of cerebral vasospasm and delayed ischemic deficits and improves clinical outcome after severe subarachnoid hemorrhage.
Barth
Martin
M
Department of Neurosurgery, University Hospital Mannheim, Faculty for Clinical Medicine of the Karl-Ruprecht-University of Heidelberg, Mannheim, Germany.
Capelle
Hans-Holger
HH
Weidauer
Stephan
S
Weiss
Christel
C
Münch
Elke
E
Thomé
Claudius
C
Luecke
Thomas
T
Schmiedek
Peter
P
Kasuya
Hidetoshi
H
Vajkoczy
Peter
P
D000328:Adult; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004311:Double-Blind Method; D004343:Drug Implants; D005260:Female; D006801:Humans; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000453:epidemiology; D008875:Middle Aged; D009529:Nicardipine / Q000008:administration & dosage*; D011446:Prospective Studies; D011859:Radiography; D013345:Subarachnoid Hemorrhage / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome; D020301:Vasospasm, Intracranial / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000453:epidemiology
D003692:Delayed-Action Preparations; D004343:Drug Implants; D009529:Nicardipine