NCT07643493

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
34mo left

Started Aug 2026

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 3, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

May 12, 2026

Last Update Submit

July 24, 2026

Conditions

Tissue Plasminogen ActivatorIntraventricular Brain Hemorrhage

Outcome Measures

Primary Outcomes (2)

  • Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion on the Speed of Intraventricular Hemorrhage (IVH) Clearance

    Assess through measurement of blood volume seen on imaging in the form of daily Head CT or Head MRI

    Enrollment through 90 days

  • Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion on Ventricular Catheter Liberalization

    Record duration of time catheter is in place. Timepoints will be recorded from the medical record.

    Enrollment through 90 days

Secondary Outcomes (10)

  • Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion on the Inflammatory Proteomic Profile in Cerebrospinal Fluid (CSF) in Patients with Irrigating Ventricular Catheters

    Baseline through 10 days

  • Assess the Presence of Tissue Plasminogen Activator (TPA) within the Cerebrospinal Fluid (CSF) Following Administration

    Baseline through 10 days

  • Assess the Breakdown of Tissue Plasminogen Activator (TPA) within the Cerebrospinal Fluid (CSF) Following Administration

    Baseline through 10 days

  • Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Shunt Dependency

    Baseline through 90 days

  • Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Functional Outcomes

    Baseline through 90 days

  • +5 more secondary outcomes

Study Arms (2)

Isotonic solution irrigation

ACTIVE COMPARATOR
Procedure: Isotonic solution

Isotonic solution irrigation + TPA Infusion

EXPERIMENTAL
Drug: Tissue Plasminogen Activator (tPA)

Interventions

Isotonic solutionPROCEDURE

Isotonic solution irrigation delivered through the CleaRRAflow catheter into the ventricular system to promote intraventricular hemorrhage clearance.

Isotonic solution irrigation
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 irrigation + TPA Infusion

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, age 18 years and older
  • Intraventricular hemorrhage requiring EVD placement for treatment as determined by the cerebrovascular neurosurgical faculty member caring for the patient as per standard of care
  • Baseline mRS 0 or 1
  • Consenting requirements met as outlined below

You may not qualify if:

  • IVH of traumatic origin
  • Inability to initiate treatment within 24 hours of presentation
  • Incarcerated individuals, pregnant individuals, or other conditions as deemed by the investigator to potentially confound study data
  • Presence of evidence of severe brainstem dysfunction on presentation (absence of brain stem reflexes, fixed/dilated pupils)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UKHC

Lexington, Kentucky, 40536-0298, United States

Location

MeSH Terms

Interventions

Tissue Plasminogen ActivatorIsotonic Solutions

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological FactorsSolutionsPharmaceutical Preparations

Central Study Contacts

Jennifer R Isaacs, MS, MS

CONTACT

859-323-4738jennifer.isaacs@uky.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 12, 2026

First Posted

June 11, 2026

Study Start

August 3, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2029

Last Updated

July 27, 2026

Record last verified: 2026-07

Locations

US(1)