Status:
UNKNOWN
ACTIVE Study - Use of ACTIVE Fluid Exchange to Treat Intraventricular Hemorrhage
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
IRRAS
Conditions:
Intraventricular Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomised controlled trial evaluating active irrigation using IRRAflow device in patients with intraventricular hemorrhages (IVH). Patients will be randomized in a 1:1 fashion to IRRAflow active irri...
Detailed Description
Intraventricular extension of hemorrhage (IVH) is a particularly poor prognostic sign, with expected mortality between 50% and 80%. IVH is a significant and independent contributor to morbidity and mo...
Eligibility Criteria
Inclusion
- Age ≥ 18 years of age
- Intraventricular hemorrhage documented on head CT or MRI scan, no older than 24 hrs.
- Intraventricular hemorrhage Graeb Score ≥3 points
- Urgent need of cerebrospinal fluid drainage (\<24 hours)
- Deterioration of consciousness or medical sedation at the time of enrollment causing the patient to be mentally and/or physically incapacitated and legally incompetent in the decision of inclusion ("acute study" conduct).
- Indication for active treatment evaluated by the treating physicians
- Use of validated anti-conception in fertile female participants in concordance with guidelines provided by the Danish Health and Medicines Authority or a negative urine human chorion gonadotropin (HCG) test.
Exclusion
- Patient has fixed and dilated pupils
- Pregnant or nursing women (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy)
Key Trial Info
Start Date :
January 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05204849
Start Date
January 13 2022
End Date
February 1 2025
Last Update
February 10 2022
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark