Tissue Plasminogen ActivatorPhase 4NCT07643493
CleaRRAflow: Isotonic Solution vs. TPA for IVH Clearance
A Phase 4 study testing Tissue Plasminogen Activator (tPA) and Isotonic solution in people with Tissue Plasminogen Activator and Intraventricular Brain Hemorrhage, run by David Dornbos at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tissue Plasminogen Activator, Intraventricular Brain Hemorrhage
- What is being tested?
- Tissue Plasminogen Activator (tPA) and Isotonic solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2026to 31 May 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Tissue Plasminogen Activator (tPA), Isotonic solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 solutionProcedure or surgery
Isotonic solution irrigation delivered through the CleaRRAflow catheter into the ventricular system to promote intraventricular hemorrhage clearance.
| Study group | Role | What they receive |
|---|---|---|
| Isotonic solution irrigation | Active comparator | Not described Receives: Procedure: Isotonic solution |
| Isotonic solution irrigation + TPA Infusion | Experimental | Not described Receives: Drug: Tissue Plasminogen Activator (tPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Using Meso scale discovery (MSD) platform with inflammatory marker panels, the proteomic profile of CSF will be evaluated.
Measured: Baseline through 10 days
Assess the Presence of Tissue Plasminogen Activator (TPA) within the Cerebrospinal Fluid (CSF) Following Administration
ELISA assay will be utilized to determine if TPA is present in CSF samples.
Measured: Baseline through 10 days
Assess the Breakdown of Tissue Plasminogen Activator (TPA) within the Cerebrospinal Fluid (CSF) Following Administration
ELISA assay will be utilized to determine the concentration of TPA present in CSF samples.
Measured: Baseline through 10 days
Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Shunt Dependency
Absence or Placement of shunt will be recorded from the clinical/medical record.
Measured: Baseline through 90 days
Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Functional Outcomes
Modified Rankin Score at Baseline, Discharge, and 90 day time points.
Measured: Baseline through 90 days
Assess the impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Mortality
Medical records will be reviewed and mortality will be documented at discharge and 90 days.
Measured: Baseline through 90 days
Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Ventilator Days
Medical records will be reviewed and number of days on ventilator will be documented.
Measured: 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
Medical records will be reviewed and number of days in the ICU will be documented.
Measured: 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
Medical records will be reviewed and number of days in the hospital will be documented.
Measured: Baseline through 90 days
Assess the Impact of Continuous Tissue Plasminogen Activator (TPA) Infusion in Patients with an Irrigating Ventricular Catheter on Hospitalization Costs
Hospitalization costs will be assessed by combining above outcome measures (ICU length of stay, time on ventilator, overall length of stay)
Measured: Baseline through 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start31 Jul 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue Plasminogen ActivatorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Dornbos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Dornbos, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643493
- Sponsor's protocol ID
- 104139
- Status last verified
- Jul 2026
- First submitted
- 12 May 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Continuous Intrathecal TPA Infusion for IVH Clearance With Ventricular Irrigation
- ClinicalTrials.gov ID
- NCT07643493
- Acronym / sponsor ID
- 104139
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- David DornbosUniversity, hospital or other
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotonic solution irrigation | Active comparator | Procedure: Isotonic solution |
| Isotonic solution irrigation + TPA Infusion | Experimental | Drug: Tissue Plasminogen Activator (tPA) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Plasminogen Activator (tPA)Tissue Plasminogen Activator (tPA) is infused through the ClearRRAflow catheter into the ventricular system to promote clearance of intraventricular hemorrhage. | Drug | Isotonic solution irrigation + TPA Infusion |
| Isotonic solutionIsotonic solution irrigation delivered through the CleaRRAflow catheter into the ventricular system to promote intraventricular hemorrhage clearance. | Procedure or surgery | Isotonic solution irrigation |
Primary outcome
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
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.
10 secondary outcomes
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
Assess the Presence of Tissue Plasminogen Activator (TPA) within the Cerebrospinal Fluid (CSF) Following Administration
Time frame: 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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tissue Plasminogen Activator (tPA) and Isotonic solution in people with Tissue Plasminogen Activator and Intraventricular Brain Hemorrhage, run by David Dornbos at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.