At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 500 enrolled

Drug / intervention

Alteplase +1 moredrug

Likely dose

Alteplase 1.0 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00784134

NCT00784134Phase 3Completed

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Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

Johns Hopkins University·interventional·Posted Nov 3, 2008·Updated Dec 5, 2018

In Brief

A Phase 3 clinical trial evaluating Alteplase and Normal saline for Intraventricular Hemorrhage. Completed, enrolled 500 participants across 81 sites in 9 countries.

Detailed Summary

The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH \< 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsIntraventricular Hemorrhage

CountriesBrazil, Canada, Germany, Hungary, Israel, Spain, Switzerland, United Kingdom, United States

CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS), Genentech, Inc., Emissary International LLC

Timeline

Phase 3CompletedFinished

200920102011201220132014201520162017201820192020202120222023202420252026

First PostedNov 2008

Enrollment StartJul 2009

Primary CompletionJul 2015

Study CompletionJan 2016

TodayJul 2026

First PostedNov 3, 2008

Enrollment StartJul 1, 2009

Primary CompletionJul 1, 2015

Study CompletionJan 1, 2016

TodayJul 2, 2026

Enrollment to primary: 6 yearsPosted 17.7 years ago

Interventions

Alteplasedrug

1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses

Normal salineother

1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses