Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
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).
Stanford is now accepting new patients for this trial.
- Chitra Venkatasubramanian, MBBS, MD, MSc.
- Neil Schwartz, MD, PhD
- Anna Finley Caulfield, MD
- Gregory W. Albers, MD
- Maarten Lansberg, MD, PhD
- Marion S. Buckwalter, MD, PhD
- drug : Cathflo Activase
- other : Normal saline
Phase: Phase 3
Ages Eligible For Study:
- 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