Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChristopher P Kellner
About this trial
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 criteria
Qualifiers
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
Disqualifiers
GCS ≤ 5
Pregnancy
Fixed and dilated pupil
Life-threatening medical condition
Trial design
Treatments tested in this trial
- IRRAflow® CNS (Active Fluid Exchange) System
Treatment groups
250 Participants
are divided into 1 treatment groupSponsors and collaborators
Christopher P Kellner
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
IRRAS
Collaborator
Source ClinicalTrials.gov