Phase II, randomized, pharmokinetic, dose finding, and dose frequency determination using rt-PA in intraventricular hemorrhage - CLEAR IVH

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000919-26-GB

Enrollment

Registered

2005-06-17

Start date

2005-07-29

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral haemorrhage with intraventricular extension

Interventions

Trade Name: CathFlo Activase (Alteplase) Product Name: CathFlo Activase (Alteplase) Product Code: Cathflo Pharmaceutical Form: Powder for solution for i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Spontaneous intracerebral haemorrhage 90 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Suspected or untreated aneurysm or arteriovenous malformation, clotting disorders, platelet count 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the pharmokinetics, appropriate dose and dose frequency of intraventricular injections of multiple low doses of rt-PA This application is specifically for the dose frequency phase. ;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	—

Measure

Time frame

Main Objective: To determine the pharmokinetics, appropriate dose and dose frequency of intraventricular injections of multiple low doses of rt-PA This application is specifically for the dose frequency phase. ;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

—

Countries

Finland, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026