|CLEAR III Protocol Abstract in International Journal of Stroke Version:Aug 2013|
Int J Stroke. 2013 Aug 28. doi: 10.1111/ijs.12097. [Epub ahead of print]
A multicenter, randomized, double-blinded, placebo-controlled phase III study of Clot Lysis Evaluation of Accelerated Resolution of Intraventricular Hemorrhage (CLEAR III).
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; CLEAR III Investigators.
Division of Neurosciences Critical Care, Department of Neurology, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
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 (
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 24 h of the computed tomography scan confirmed IVH and third or fourth ventricle obstruction, with or without supratentorial intracerebral haemorrhage volume
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 The Authors. International Journal of Stroke © 2013 World Stroke Organization.
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