Status:
COMPLETED
Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Genentech, Inc.
Conditions:
Intraventricular Hemorrhage
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 practic...
Eligibility Criteria
Inclusion
- Age 18-80
- Symptom onset less than 24 hrs prior to diagnostic CT scan
- Spontaneous ICH less than or equal to 30 cc or primary IVH
- IVH obstructing 3rd and/or 4th ventricles
- ICH clot stability at 6 hours or more post IVC placement
- IVH clot stability at 6 hours or more post IVC placement
- Catheter tract bleeding stability 6 hours or more post IVC placement
- EVD placed per standard medical care
- SBP less than 200 mmHg sustained for 6 hours prior to drug administration
- Able to randomize within 72 hours of diagnostic CT scan
- Historical Rankin of 0 or 1
Exclusion
- Suspected or untreated ruptured cerebral aneurysm, AVM, or tumor
- Presence of a choroid plexus vascular malformation or Moyamoya
- Clotting disorders
- Platelet count less than 100,000, INR greater than 1.4
- Pregnancy
- Infratentorial hemorrhage
- SAH at clinical presentation
- ICH/IVH enlargement that cannot be stabilized in the treatment time window
- Ongoing internal bleeding
- Superficial or surface bleeding
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Planned or simultaneous participation (between screening and Day-30) in another interventional medical investigation or clinical trial.
- No subject or legal representative to give written informed consent
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00784134
Start Date
July 1 2009
End Date
January 1 2016
Last Update
December 5 2018
Active Locations (81)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Mayo Clinic, Arizona
Phoenix, Arizona, United States, 85054
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
4
University of Southern California - Keck School of Medicine
Los Angeles, California, United States, 90089