Utility of Continuous Intrathecal TPA Infusion for IVH Clearance With Ventricular Irrigation
David Dornbos
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.
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…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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 brain…
Interventions
- DrugTissue Plasminogen Activator (tPA)
Tissue Plasminogen Activator (tPA) is infused through the ClearRRAflow catheter into the ventricular system to promote clearance of intraventricular hemorrhage.
- ProcedureIsotonic solution
Isotonic solution irrigation delivered through the CleaRRAflow catheter into the ventricular system to promote intraventricular hemorrhage clearance.
Location
- UKHCLexington, Kentucky