COMPLETED

The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of Intraventricular Hemorrhage (IVH)

Conditions

Intraventricular Hemorrhage Subarachnoid Hemorrhage interventricular hemorrhage

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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 primary goal of this study is to assess the occurrence of flushing interventions to address occlusions during the treatment of interventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm).

Official Title

A Prospective, Multicenter Study to Evaluate the Performance and Safety of the CerebroFlo™ EVD Catheter

Quick Facts

Study Start:2021-09-15

Study Completion:2025-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05113381

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 Criteria	Exclusion Criteria
1. Subject and/or legally authorized representative has reviewed the Institutional Review Board (IRB)-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB-approved consent form. 2. Subject is ≥ 18 years of age at the time of consent. 3. Subjects with intraventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm) who have had CerebroFlo™ EVD Catheter(s) placed without complication. 4. Subjects who require only one EVD Catheter at initial admission	1. Subjects with a scalp infection present. 2. Subjects with uncorrectable coagulopathy due to prior administration of anticoagulants at the time the CerebroFlo™ EVD Catheter(s) is placed. 3. Subjects known to have a bleeding diathesis. 4. Subjects in which the CerebroFlo™ EVD Catheter(s) is placed directly into a hematoma 5. Evidence of catheter-associated hemorrhage from insertion of the CerebroFlo EVD Catheter(s) on post-placement CT scan. 6. Subject is pregnant

Inclusion Criteria

Exclusion Criteria

1. Subject and/or legally authorized representative has reviewed the Institutional Review Board (IRB)-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB-approved consent form.
2. Subject is ≥ 18 years of age at the time of consent.
3. Subjects with intraventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm) who have had CerebroFlo™ EVD Catheter(s) placed without complication.
4. Subjects who require only one EVD Catheter at initial admission

1. Subjects with a scalp infection present.
2. Subjects with uncorrectable coagulopathy due to prior administration of anticoagulants at the time the CerebroFlo™ EVD Catheter(s) is placed.
3. Subjects known to have a bleeding diathesis.
4. Subjects in which the CerebroFlo™ EVD Catheter(s) is placed directly into a hematoma
5. Evidence of catheter-associated hemorrhage from insertion of the CerebroFlo EVD Catheter(s) on post-placement CT scan.
6. Subject is pregnant

Contacts and Locations

Principal Investigator

Ramesh Grandhi, MD

PRINCIPAL_INVESTIGATOR

University of Utah Health

Jason Marzuola, MSN

STUDY_DIRECTOR

Integra Life Sciences

Study Locations (Sites)

Loma Linda University Health

Loma Linda, California, 92350

United States

Stanford University

Palo Alto, California, 94304

United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

AdventHealth Orlando

Orlando, Florida, 32803

United States

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808

United States

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029

United States

Wright State University/Premier Health

Dayton, Ohio, 45409

United States

University of Texas Health Science Center

San Antonio, Texas, 78229

United States

University of Utah Health

Salt Lake City, Utah, 84123

United States

Virginia Commonwealth University Department of Neurosurgery

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Integra LifeSciences Corporation

Ramesh Grandhi, MD, PRINCIPAL_INVESTIGATOR, University of Utah Health
Jason Marzuola, MSN, STUDY_DIRECTOR, Integra Life Sciences

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 Date2021-09-15

Study Completion Date2025-07-31

Study Record Updates

Study Start Date2021-09-15

Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

interventricular hemorrhage

Additional Relevant MeSH Terms

Intraventricular Hemorrhage
Subarachnoid Hemorrhage