Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III)

Johns Hopkins University

Status and phase

Completed

Phase 3

Conditions

Intraventricular Hemorrhage

Treatments

Other: Normal saline

Drug: Alteplase

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00784134

IVH06

5U01NS062851-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment

500 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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 randomize 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 1.4
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