Clinical Research Directory
Browse clinical research sites, groups, and studies.
KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
Sponsor: SterileCare Inc.
Summary
A multi-site, randomized, 2-arm open-label trial to determine if 4% Tetrasodium (EDTA) catheter lock solution is more effective than heparin lock (standard of care) in preventing central venous catheter occlusions in children with intestinal failure (IF) on total parenteral nutrition (TPN).
Official title: Safety and Effectiveness of 4% Tetrasodium Ethylenediaminetetraacetic Acid Catheter Lock Solution in Preventing Central Venous Catheter Occlusions in Children With Intestinal Failure: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
4 Weeks - 18 Years
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2024-06-21
Completion Date
2026-06
Last Updated
2025-11-12
Healthy Volunteers
No
Conditions
Interventions
KiteLock 4% Sterile Catheter Lock Solution
KiteLock™ is a clear, colorless, and sterile 4% (40 mg/ml) tetrasodium EDTA solution that contains no preservatives, latex, antibiotics, or ethanol and is nonpyrogenic. Tetrasodium salt of EDTA has been shown to disrupt in vivo and ex vivo-generated biofilms by destabilizing the structural integrity of micro-organisms at the cellular level.
Heparin Lock Solution
Nonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection.
Locations (8)
Boston Children's Hospital
Boston, Massachusetts, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Columbia University Irving Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Cook Children's Health Care System
Fort Worth, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States