CLEAR III
Research type
Research Study
Full title
Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
IRAS ID
9523
Sponsor organisation
The Johns Hopkins University
Eudract number
2008-006916-39
Clinicaltrials.gov Identifier
Research summary
This international study is coordinated from Johns Hopkins University, USA and will recruit 500 patients. It is funded by NIH/NINDS and Genentech, Inc. The research will determine if a drug named recombinant tissue plasminogen activator (rt-PA), which dissolves blood clots improves recovery in patients with brain blood clots when compared to placebo (flud that does not dissolve blood clots). rt-PA may more rapidly remove clots. This study is necessary because although rt-PA has been approved for certain uses in humans, it is not yet approved for dissolving blood clots in the brain. This study is for people with intraventricular hemorrhage (bleeding in the brains ventricles or open spaces), who are to receive an intraventricular catheter (IVC). IVC catheters are inserted into the ventricles of the brain.Initial investigations will include a physical medical history, physical examination, blood and urine tests, tests of neurological condition, and CT scans. Patients will then be randomly assigned (like flipping a coin) to one of two groups. Patients in the IVC rt-PA group will receive rt-PA through the IVC up to 12 times. Patients in the IVC placebo group will receive normal saline through the IVC up to 12 times. Intravenous antibiotics and regular CT scans of the head will be performed following IVC placement and rt-PA injections so that patients avoid infections and are carefully monitored. Patients will return to clinic at 1, 6, and 12 months for follow-up CT scans and neurological examinations. These visits will take about 2 hours and will be video recorded. At 3 and 9 months patients will receive telephone follow ups that will take about 30 minutes.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
09/H0505/71
Date of REC Opinion
23 Jul 2009
REC opinion
Further Information Favourable Opinion