CleaRRAflow: Isotonic Solution vs. TPA for IVH Clearance

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

First listed

Jun 11, 2026

Start date

Jul 31, 2026

Status verified

Jul 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 ]

Locations (1)

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