Home › Intracranial Hemorrhages › NCT06649097
Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
RecruitingObservational study
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- IRRAflow® CNS (Active Fluid Exchange) System (device)
Sponsor: Christopher P Kellner · Participants: 250 · Started: Sep 25, 2025
Contact the study team
- Sukaina Davdani · Phone: (212) 241-2524
- Sydney Edwards · Phone: (212) 241-2524
Official record on ClinicalTrials.gov — NCT06649097
Locations in the U.S.
| New York | Icahn School of Medicine at Mount Sinai, New York |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.