CleaRRAflow: Isotonic Solution vs. TPA for IVH Clearance

June 8, 2026 updated by: David Dornbos

Utility of Continuous Intrathecal TPA Infusion for IVH Clearance With Ventricular Irrigation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a prospective randomized trial, evaluating the impact of continuous tissue plasminogen activator (TPA) infusion in the setting of intraventricular hemorrhage (IVH) with blinded endpoint adjudication. This trial will enroll adult patients admitted to the University of Kentucky with substantial IVH (primary IVH, intracranial hemorrhage [ICH] with IVH, and IVH secondary to subarachnoid hemorrhage [SAH]). Patients will undergo placement of an irrigating ventricular catheter as per standard of care. Ventricular catheter placement will occur in all patients at the discretion of the neurosurgical team. Procedural consent will proceed per institutional standard of care.

Following irrigating ventricular catheter placement, irrigation and drainage will occur as per standard of care. Current use of intrathecal TPA for large-volume IVH burden is left to the discretion of the attending neurosurgeon. No standard of care exists as to its current clinical use, and it is often used, although sporadically in this patient population. Following device placement and initiation of irrigation, informed consent will be obtained by the neurosurgical research team. Following consent of either the patient or LAR, patients will be randomized in a 1:1 permuted block fashion to receive either irrigation alone or irrigation with continuous TPA infusion.

Initiation of continuous TPA infusion should start within approximately 24 hours of drain placement. As per standard of care, daily head computed tomography (HCT) scans should be obtained. Irrigation rates of normal isotonic solution typically range from 30-90 cc/hour, depending on patient tolerance and intracranial pressure. Subjects randomized to the TPA arm will have the same range of irrigation rates, with the dose of TPA infused ranging from 4-6 mg/day.

CSF should be collected from patients enrolled in the study following enrollment but prior to randomization and TPA initiation and then daily for up to 10 days. Collected CSF will then be assessed using MSD proteomics and ELISA assays to assess the inflammatory response, intercellular signaling, and breakdown products of hematoma and TPA. Patient outcomes (ICU length of stay, overall LOS, disposition, NIHSS scores, and functional outcomes) will be collected and assessed as available in the clinical record.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Isotonic solution irrigation
Procedure: Isotonic solution
Isotonic solution irrigation delivered through the CleaRRAflow catheter into the ventricular system to promote intraventricular hemorrhage clearance.
Experimental: Isotonic solution irrigation + TPA Infusion
Drug: Tissue Plasminogen Activator (tPA)
Tissue Plasminogen Activator (tPA) is infused through the ClearRRAflow catheter into the ventricular system to promote clearance of intraventricular hemorrhage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion on the Speed of Intraventricular Hemorrhage (IVH) Clearance
Time Frame: Enrollment through 90 days
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
Time Frame: Enrollment through 90 days
Record duration of time catheter is in place. Timepoints will be recorded from the medical record.
Enrollment through 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline through 10 days
Using Meso scale discovery (MSD) platform with inflammatory marker panels, the proteomic profile of CSF will be evaluated.
Baseline through 10 days
Assess the Presence of Tissue Plasminogen Activator (TPA) within the Cerebrospinal Fluid (CSF) Following Administration
Time Frame: Baseline through 10 days
ELISA assay will be utilized to determine if TPA is present in CSF samples.
Baseline through 10 days
Assess the Breakdown of Tissue Plasminogen Activator (TPA) within the Cerebrospinal Fluid (CSF) Following Administration
Time Frame: Baseline through 10 days
ELISA assay will be utilized to determine the concentration of TPA present in CSF samples.
Baseline through 10 days
Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Shunt Dependency
Time Frame: Baseline through 90 days
Absence or Placement of shunt will be recorded from the clinical/medical record.
Baseline through 90 days
Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Functional Outcomes
Time Frame: Baseline through 90 days
Modified Rankin Score at Baseline, Discharge, and 90 day time points.
Baseline through 90 days
Assess the impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Mortality
Time Frame: Baseline through 90 days
Medical records will be reviewed and mortality will be documented at discharge and 90 days.
Baseline through 90 days
Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Ventilator Days
Time Frame: Baseline through 90 days
Medical records will be reviewed and number of days on ventilator will be documented.
Baseline through 90 days
Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on ICU Length of Stay
Time Frame: Baseline through 90 days
Medical records will be reviewed and number of days in the ICU will be documented.
Baseline through 90 days
Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Hospital Length of Stay
Time Frame: Baseline through 90 days
Medical records will be reviewed and number of days in the hospital will be documented.
Baseline through 90 days
Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Hospitalization Costs
Time Frame: Baseline through 90 days
Hospitalization costs will be assessed by combining above outcome measures (ICU length of stay, time on ventilator, overall length of stay)
Baseline through 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Dornbos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2029

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104139

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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