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Recruiting NCT05118997

Active Removal of IntraCerebral Hematoma Via Active Irrigation

Trial Parameters

Condition Cerebral Hemorrhage
Sponsor IRRAS
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-10-25
Completion 2025-07
Interventions
IRRAflowEVD

Brief Summary

Study evaluating if active irrigation by IRRAflow® with infusion of tPA will reduce the time needed for clearance of intracerebral and intraventricular hemorrhage compared with passive drainage.

Eligibility Criteria

Inclusion Criteria: 1. Age \>18 years of age 2. Need of EVD 3. Active treatment 4. Signed informed consent obtained a. Based on institutional and country laws 5. Spontaneous ICH with maximum 30 square cm's 6. If needed, normal coagulation profile (PT, PTT, platelet count) 7. Treatment within 72 hours of ictus 8. Ability to administer 2.0 mg of tPA per day for 3 days Exclusion Criteria: 1. Age \< 18 years 2. No need of EVD 3. Patient has fixed and dilated pupils 4. Coagulopathy uncorrectable 5. Vascular pathology (e.g. Aneurysm involvement, AVM involvement) 6. Pregnant women

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