CLEAR INTRAVENTRICULAR HEMORRHAGE TRIAL

Does faster clot removal give better patient outcomes in IVH?

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Intraventricular Hemorrhage - More than a Glimmer of Hope

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Editorial by Heinrich Mattle and Andreas Raabe published in Stroke 25-Aug-2011 discussing Naff's article on the CLEAR Phase-II IVH Thrombolysis study results.





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2011-11-11 16:06:15
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Naff's article on CLEAR IVH Trial (Phase 2) Results

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Article in STROKE August 2011 by Neal Naff and Daniel Hanley presenting results of the CLEAR Phase 2 IVH Thrombolysis study results.





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2011-11-11 16:13:08
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Factors Affecting Clot Lysis Rates in Patients With Spontaneous Intraventricular Hemorrhage

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An article in Stroke May 2012 showing that, in addition to rt-PA usage, high baseline plasminogen levels and low platelet count are also correlated with clot lysis rates in patients with spontaneous intraventricular hemorrhage.





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2012-06-13 14:39:28
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Drainage Efficiency with Dual Versus Single Catheters in Severe Intraventricular Hemorrhage

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An article in Neurocritical Care 2011 showing that the use of dual simultaneous catheters may be useful in patients with large IVH.





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2012-06-13 14:45:03
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Low-Dose Recombinant Tissue-Type Plasminogen Activator Enhances Clot Resolution in Brain Hemorrhage

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Article published in Stroke 2011 addressing the safety and efficacy of low-dose recombinant tissue-type plasminogen activator in the CLEAR IVH trial.





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2012-06-20 11:35:43
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Systemic hematologic status following intraventricular recombinant tissue-type plasminogen activator for intraventricular hemorrhage: the CLEAR IVH Study Group

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A Stroke 2011 article analyzing the systemic hematologic status of patients enrolled in the CLEAR IVH clinical trial.





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2012-06-20 11:43:18
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Resolution of Intraventricular Hemorrhage Varies by Ventricular Region and Dose of Intraventricular Thrombolytic

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A Stroke 2012 article showing that IVH clearance is dependent on dose and ventricular region.





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2012-06-20 11:48:25
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Occurrence and impact of intracranial pressure elevation during treatment of severe intraventricular hemorrhage

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A Critical Care Medicine 2012 article showing how often ICP elevation occurs in severe IVH and its impact on functional outcomes.





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2012-06-20 11:53:34
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Safety of Intraventricular Hemorrhage (IVH) Thrombolysis Based on CT Localization of External Ventricular Drain (EVD) Fenestrations and Analysis of EVD Tract Hemorrhage

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A Neurocritical Care 2012 article showing that intraventricular rt-PA therapy is relatively safe with respect to EVD tract hemorrhages, and that the amount of catheter fenestrations contained within the ventricle at placement appears to increase the safety of the procedure.





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2012-06-20 16:18:31
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When Numbers Reveal the Bleeding Obvious

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This article about CLEAR-III appears in the Spring 2010 NeuroLogic, a Johns Hopkins Medicine newsletter from the Departments of Neurology and Neurosurgery.





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2013-04-07 13:52:21
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Lisa Yanase - New Hope for Brain Hemorrhage: CLEAR III Trial

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This article about the CLEAR-III trial was written by Dr. Lisa Yanase, an investigator for the Providence clinical site.





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2013-04-07 14:06:25
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Low-Dose rtPA Hastens Clot Removal in Brain Hemorrhage Version:15-Nov-11

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Excerpt from a Medscape CME course from Nov-2012 about the CLEAR phase II results in 48 patients with intraventricular hemorrhage (IVH).





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2013-04-07 14:25:45
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CLEAR Result: Low-Dose tPA Safe, Effective in Treating Intraventricular Hemorrhage Version:15-May-2008

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This news article from Medscape discusses the presentation of the CLEAR phase II results at the European Stroke Conference in 2008.





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2013-04-07 14:48:52
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CLEAR III Protocol Abstract in International Journal of Stroke Version:Aug 2013

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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).

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Division of Neurosciences Critical Care, Department of Neurology, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Abstract

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 (

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 24 h of the computed tomography scan confirmed IVH and third or fourth ventricle obstruction, with or without supratentorial intracerebral haemorrhage volume

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 The Authors. International Journal of Stroke © 2013 World Stroke Organization.





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2013-10-09 15:46:36
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