Phase II, randomized, pharmokinetic, dose finding, and dose frequency determination using rt-PA in intraventricular hemorrhage - CLEAR IVH
- Conditions
- Intracerebral haemorrhage with intraventricular extension
- Registration Number
- EUCTR2004-000919-26-FI
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 52
Spontaneous intracerebral haemorrhage < 30cc, intraventricular haemorrhage (IVH), intraventricular catheter (IVC) placed as standard care, systolic BP>90 mmHg and <185 mmHg, diastolic BP <105 mmHg, pre ICH rankin of 0 or 1, age 18-75, clot size 6 hrs after IVC placement must be within 5cc of presenting clot size, able to receive first dose within 48 hours of CT scan diagnosing IVH, symptom onset to diagnostic CT , 12 hrs.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Suspected or untreated aneurysm or arteriovenous malformation, clotting disorders, platelet count < 100,000, INR > 1.7, PT > 15s, elevated APTT, ICH enlargement in 6 hours after placement of intraventricular catheter, internal or surface bleeding, any other condition that would pose a significant hazard to the subject if investigational therapy were initiated
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: To determine the pharmokinetics, appropriate dose and dose frequency of intraventricular injections of multiple low doses of rt-PA<br><br> This application is specifically for the dose frequency phase.<br> ;Secondary Objective: To test if this intervention facilitates more rapid clot resolution, complete recovery of function and decreased mortality;Primary end point(s): 30 day mortality, incidence of ventriculitis, meningitis, rate of bleeding events
- Secondary Outcome Measures
Name Time Method