gms | German Medical Science

63rd Annual Meeting of the German Society of Neurosurgery (DGNC)
Joint Meeting with the Japanese Neurosurgical Society (JNS)

German Society of Neurosurgery (DGNC)

13 - 16 June 2012, Leipzig

Article

Send article

Prospective randomized phase II trial on concomitant intraventricular thrombolysis and low-frequency head-motion after severe subarachnoid hemorrhage

Meeting Abstract

Search Medline for

  • N. Etminan - Neurochirurgische Klinik, Heinrich-Heine-Universität, Düsseldorf
  • S.O. Eicker - Neurochirurgische Klinik, Heinrich-Heine-Universität, Düsseldorf
  • K. Beseoglu - Neurochirurgische Klinik, Heinrich-Heine-Universität, Düsseldorf
  • H.J. Steiger - Neurochirurgische Klinik, Heinrich-Heine-Universität, Düsseldorf
  • D. Hänggi - Neurochirurgische Klinik, Heinrich-Heine-Universität, Düsseldorf

Deutsche Gesellschaft für Neurochirurgie. Japanische Gesellschaft für Neurochirurgie. 63. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), Joint Meeting mit der Japanischen Gesellschaft für Neurochirurgie (JNS). Leipzig, 13.-16.06.2012. Düsseldorf: German Medical Science GMS Publishing House; 2012. DocP 065

doi: 10.3205/12dgnc452, urn:nbn:de:0183-12dgnc4529

Published: June 4, 2012

© 2012 Etminan 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: Our previous non-randomized studies on intraventricular thrombolysis and kinetic therapy demonstrated a positive effect on angiopgraphic vasopasm and functional outcome in patients suffering from aneurysmal subarachnoid hemorrhage (SAH). The goal of the present randomized phase II study was to investigate the effect of concomitant low-frequency head-motion therapy and intraventricular thrombolysis in patients suffering from severe SAH.

Methods: For this prospective, randomized Phase II study, 60 patients suffering from severe SAH (WFNS III-V) were randomized into experimental or control treatment. Experimental therapy consisted of intraventricular application of rt-PA (Actilyse®) (5 mg bolus every 12 hours) and lateral rotational therapy (RotoRest®, KCI) for 48 hours after treatment of the aneurysm; the control group received treatment as usual. The primary endpoint was defined as functional outcome, as measured by Glasgow Outcome Scale (GOS) at discharge. Clot clearance rate, radiological vasospasm, new cerebral infarction, posthemorrhagic hydrocephalus and GOS at 3 months were defined as secondary endpoints. Radiological vasospasm was defined as angiographic and/or perfusion CT (PCT) vasospasm.

Results: Of a total of 60 patients, 47 (78.3%) suffered from WFNS °IV or V SAH. No serious adverse events due to the experimental therapy were detected. Clot clearance rate was significantly higher in the experimental group, as compared to control group (p<0.001 for cranial slices and p<0.001 for basal slices). However, the incidence of radiological vasospasm, new cerebral infarction and hydrocephalus did not differ between the two groups Lastly, there was no statistical difference in functional outcome at discharge and after 3 months between the two groups.

Conclusions: Despite a significant reduction of subarachnoidal clot, concomitant intraventricular thrombolysis and kinetic therapy does not reduce the incidence of angiographic vasospasm, new cerebral infarction or poor functional outcome in patients suffering from severe SAH.