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NCT05649904
AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
Conditions: Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, Ventriculitis
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 240
Sponsor: Ohio State University
Summary
The goal of this clinical trial is to evaluate efficacy and safety of evacuation of cerebrospinal fluid, blood, and harmful bacteria from the intraventricular, subdural and subarachnoid spaces by Active Controlled Irrigation and Drainage (IRRAflow) compared to Passive External Ventricular Drainage (EVD).Subjects with intraventricular hemorrhage, subarachnoid hemorrhage, subdural bleeding, and ventriculitis will be randomized to receive the IRRAflow device or EVD device and followed for one month post-procedure to compare outcomes between the subject groups.
Eligibility Criteria
Inclusion Criteria:Age ≥18 years of ageNeed of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitisIndication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitisSigned informed consent obtained by subject or Legally Authorized RepresentativeExclusion Criteria:Subject has fixed and dilated pupilsPregnant womenPresence of MoyamoyaHistory or presence of clotting disorder.Platelet count less than 100,000, INR greater than 1.4
Source: ClinicalTrials.gov (NCT05649904). StuddyBuddy aggregates publicly available trial information.