Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
Recruiting
Observational Study
Intracranial Hemorrhage
Ventriculitis
Intracranial Abscess
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 250 (estimated)
- Sponsor
- Christopher P Kellner · Other
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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.
Trial Locations
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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 wit…
Contacts