Browse by author
Lookup NU author(s): Emeritus Professor David Mendelow
Full text for this publication is not currently held within this repository. Alternative links are provided below where available.
Background: In adults, intraventricular thrombolytic therapy with recombinant tissue plasminogen activator (rtPA) facilitates resolution of intraventricular haemorrhage (IVH), reduces intracranial pressure, decreases duration of cerebrospinal fluid diversion, and may ameliorate direct neural injury. We hypothesize that patients with small parenchymal haematoma volumes (<30cc) and relatively large IVH causing acute obstructive hydrocephalus would have improved clinical outcomes when given injections of low-dose rtPA to accelerate lysis and evacuation of IVH compared with placebo. Methods: The Clot Lysis Evaluation of Accelerated Resolution of Intraventricular Hemorrhage III trial is an investigator-initiated, phase III, randomized, multicenter, double-blind, placebo-controlled study comparing the use of external ventricular drainage (EVD) combined with intraventricular injection of rtPA to EVD plus intraventricular injection of normal saline (placebo) for the treatment of IVH. Patients with known symptom onset within 24h of the computed tomography scan confirmed IVH and third or fourth ventricle obstruction, with or without supratentorial intracerebral haemorrhage volume <30cc, who require EVD are screened with a computed tomography scan at least six hours after EVD placement and, if necessary, at consecutive 12-h intervals until stabilization of any intracranial bleeding has been established. Patients who meet clinical and imaging criteria (no ongoing coagulopathy and no suspicion of aneurysm, arteriovenous malformation, or any other vascular anomaly) will be randomized to either intraventricular rtPA or placebo. Results: The primary outcome measure is dichotomized modified Rankin Scale 0-3 vs. 4-6 at 180 days. Clinical secondary outcomes include additional modified Rankin Scale dichotomizations at 180 days (0-4 vs. 5-6), ordinal modified Rankin Scale (0-6), mortality and safety events at 30 days, mortality at 180 days, functional status measures, type and intensity of intensive care unit management, rate and extent of ventricular blood clot removal, and quality of life measures. © 2013 World Stroke Organization.
Author(s): Ziai WC, Tuhrim S, Lane K, Mcbee N, Lees K, Dawson J, Butcher K, Vespa P, Wright DW, Keyl PM, Mendelow AD, Kase C, Wijman C, Lapointe M, John S, Thompson R, Thompson C, Mayo S, Reilly P, Janis S, Awad I, Hanley DF
Publication type: Article
Publication status: Published
Journal: International Journal of Stroke
Year: 2014
Volume: 9
Issue: 4
Pages: 536-542
Print publication date: 01/06/2014
Online publication date: 28/08/2013
Acceptance date: 16/04/2013
ISSN (print): 1747-4930
ISSN (electronic): 1747-4949
Publisher: Blackwell Publishing Ltd
URL: https://doi.org/10.1111/ijs.12097
DOI: 10.1111/ijs.12097
PubMed id: 24033910
Altmetrics provided by Altmetric
