RECRUITING

AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection

Quick Facts

Study Start:2023-02-07
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05649904

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥18 years of age
  2. 2. Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
  3. 3. Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
  4. 4. Signed informed consent obtained by subject or Legally Authorized Representative
  1. 1. Subject has fixed and dilated pupils
  2. 2. Pregnant women
  3. 3. Presence of Moyamoya
  4. 4. History or presence of clotting disorder.
  5. 5. Platelet count less than 100,000, INR greater than 1.4

Contacts and Locations

Study Contact

Victoria Adams
CONTACT
6146854484
victoria.adams@osumc.edu
Patrick Youssef, MD
CONTACT
6143666590
patrick.youssef@osumc.edu

Principal Investigator

Patrick Youssef, MD
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

  • Patrick Youssef, MD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-07
Study Completion Date2026-01

Study Record Updates

Study Start Date2023-02-07
Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

  • Intraventricular Hemorrhage
  • Subarachnoid Hemorrhage
  • Subdural Hematoma
  • Ventriculitis