Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

Condition(s) targeted: Intraventricular Hemorrhage

Intervention: Cathflo Activase (Drug); Normal saline (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Daniel F. Hanley, MD, Study Chair, Affiliation: Johns Hopkins University

Overall contact:
Karen Lane, CMA, CCRP, Phone: (410) 614-3461, Email: klane@jhmi.edu

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, Cathflo® Activase® 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).

Official title: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Modified Rankin Scale

Secondary outcome:

All cause mortality

Amount of residual blood

Intensity of critical care management

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 receive first dose within 72 hours of diagnostic CT scan

- Historical Rankin of 0 or 1

Exclusion Criteria:

- 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. 3, or elevated APTT

- Pregnancy

- Infratentorial hemorrhage (brainstem involvement or third nerve palsy)

- 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

Karen Lane, CMA, CCRP, Phone: (410) 614-3461, Email: klane@jhmi.edu

Johns Hopkins University, Baltimore, Maryland 21230, United States; Recruiting
Shannon Ledroux, Phone: 410-502-0505, Email: sledrou1@jhmi.edu
Wendy Ziai, MD, Phone: (410) 614-6121, Email: weziai@jhmi.edu
Wendy Ziai, MD, Principal Investigator

Starting date: July 2009
Ending date: July 2015
Last updated: July 10, 2009