Actively Recruiting

Age: 18Years +
All Genders
NCT06649097

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

Led by Christopher P Kellner · Updated on 2025-10-28

250

Participants Needed

1

Research Sites

300 weeks

Total Duration

On this page

Sponsors

C

Christopher P Kellner

Lead Sponsor

I

IRRAS

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3E=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)
Not Eligible

You will not qualify if you...

  • Glasgow Coma Scale (GCS) �3C= 5
  • Pregnancy
  • Fixed and dilated pupil
  • Life-threatening medical condition

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

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Research Team

S

Sukaina Davdani

CONTACT

S

Sydney Edwards

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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