Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System

ID#: NCT06649097

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: September 25, 2025

End Date: July 01, 2031

Contact Information:
Sukaina Davdani
(212) 241-2524
Sydney Edwards
(212) 241-2524
Summary: The study is a multi-center prospective cohort, controlled, phase 4 post-market registry evaluating the efficacy and radiographic outcomes associated with the use of the IRRAflow® Active Fluid Exchange System compared to standard of care external ventricular drains.
Eligibility:

Inclusion criteria:

- Age >=18 years of age

- Intracranial hemorrhage documented on head CT or MRI scan.

- Indication for active fluid exchange evaluated by treating physician.

- Signed informed consent obtained by patient or Legal Authorized Representative

- Scheduled enrollment and treatment within 72 hours of last known well (LKW)

Exclusion criteria:

- GCS ≤ 5

- Pregnancy

- Fixed and dilated pupil

- Life-threatening medical condition
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