AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University
About this trial
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
Qualifiers
Age ≥18 years of age
Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
Signed informed consent obtained by subject or Legally Authorized Representative
Disqualifiers
Subject has fixed and dilated pupils
Pregnant women
Presence of Moyamoya
History or presence of clotting disorder.
Trial design
Treatments tested in this trial
- IRRAflow with Active Fluid Exchange System
- External Ventricular Drain
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ohio State University
Lead sponsor
IRRAS
Collaborator
Source ClinicalTrials.gov