Intraventricular Catheter System for IVH

ID#: NCT05970549

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: June 14, 2022

End Date: December 31, 2023

Contact Information:
Christopher P Kellner, MD
212-241-2606
Trevor Hardigan, MD PhD
212-241-2606
Summary: The purpose of this research study is to evaluate the safety and outcomes associated with the use of IRRAflow® System catheters in externally draining intracranial fluid to reduce intracranial pressure. This study will be comparing the IRRAflow® system to standard of care catheters used in the same procedure. The IRRAflow® system is FDA approved for this procedure.
Eligibility:

Inclusion Criteria:

- Age >=18 years of age

- Intraventricular hemorrhage documented on head CT or MRI scan

- Need of cerebrospinal fluid drainage

- Indication for active treatment evaluated by the treating physicians

- Signed informed consent obtained by patient or Legal Authorized Representative

- Treatment possible within 72 hours of ictus

Exclusion Criteria:

- Patient has fixed and dilated pupils

- Pregnant or nursing women (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy)
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