CleaRRAflow: Isotonic Solution vs. TPA for IVH Clearance

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
David Dornbos
Study ID
NCT07643493
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Intraventricular Brain Hemorrhage
  • Tissue Plasminogen Activator

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Tissue Plasminogen Activator (tPA) — DRUG
    Tissue Plasminogen Activator (tPA) is infused through the ClearRRAflow catheter into the ventricular system to promote clearance of intraventricular hemorrhage.
  • Isotonic solution — PROCEDURE
    Isotonic solution irrigation delivered through the CleaRRAflow catheter into the ventricular system to promote intraventricular hemorrhage clearance.

Study Details

The study aims to investigate the effect of continuous tPA irrigation into the ventricles. Investigators believe it may be superior to the traditional every 8-hour bolus dosing and continuous isotonic solution irrigation alone. The protocol plans to analyze blood clearance and functional outcomes in the patients.

Key Dates

Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Isotonic solution irrigation
  • Experimental: Isotonic solution irrigation + TPA Infusion

Primary Outcome Measure

Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion on the Speed of Intraventricular Hemorrhage (IVH) Clearance [ Time Frame: Enrollment through 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UKHCLexingtonKentucky40536-0298
Jennifer Isaacs
[email protected]
8593234738

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By research site
UKHC· Lexington, KY