CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 141 enrolled
Drug / intervention
MIS+Cathflo Activase (drug) +1 moredrug
Likely dose
rt-PA 0.3 or 1.0 mg administered via catheter into intracerebral hemorrhageAI-extracted
Key inclusion· 8
  • ✓Age 18–80 years
  • ✓GCS <14 or NIHSS ≥6
  • ✓Spontaneous supratentorial intracerebral hemorrhage ≥20 cc
  • ✓Symptom onset <12 hours prior to diagnostic CT scan
Key exclusion· 14
  • ✕Infratentorial hemorrhage or midbrain/brainstem involvement
  • ✕Severe coagulopathy: platelet count <100,000, INR >1.4, or elevated PT/APTT
  • ✕Irreversible coagulopathy from medical condition or prior to randomization
  • ✕Clotting disorders

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

Search/NCT00224770
NCT00224770Phase 2Completed
CompareCT.gov

Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation

Daniel Hanley·interventional·Posted Sep 23, 2005·Updated Jun 18, 2015

In Brief

A Phase 2 clinical trial evaluating MIS+Cathflo Activase (drug) and Intraoperative stereotactic CT-Guided Endoscopic Surgery for Intracerebral Hemorrhage. Completed, enrolled 141 participants across 29 sites in 4 countries.

Detailed Summary

The purpose of this trial is to determine the safety of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The ICES arm of the trial will determine the safety of endoscopic surgery to remove ICH. All MISTIE intention to treat subjects represent the hypothesized test group. The ICES cohort is to be analyzed separately.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntracerebral Hemorrhage
CountriesCanada, Germany, United Kingdom, United States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS), Genentech, Inc., Emissary International LLC

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 23, 2005
Enrollment StartAug 1, 2005
Primary CompletionAug 1, 2012
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 20.8 years ago

Interventions

MIS+Cathflo Activase (drug)drug

MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.

Intraoperative stereotactic CT-Guided Endoscopic Surgeryprocedure

Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting arm as MISTIE arm. No rt-PA administered, and in addition to best medical care.