RecruitingNot Applicable

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

United States250 participantsStarted 2025-09-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Residual blood volume by post bleed day 5

Timeframe: Post-procedure day 5

Utility weighted modified Rankin Score

Timeframe: End of study, at 6 months

Trial details

NCT IDNCT06649097

SponsorChristopher P Kellner

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-01

Contact for this trial

Sukaina Davdani

(212) 241-2524 Sukaina.Davdani@mountsinai.org

View on ClinicalTrials.gov More Intracranial Hemorrhage trials