Actively Recruiting
KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
Led by SterileCare Inc. · Updated on 2025-11-12
124
Participants Needed
8
Research Sites
101 weeks
Total Duration
On this page
Sponsors
S
SterileCare Inc.
Lead Sponsor
D
Dicentra Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Managed by an intestinal rehabilitation program at a participating center
- Diagnosis of intestinal failure with need for parenteral nutrition support for more than 60 days in the previous 74 days due to primary intestinal disease
- Expected need for parenteral nutrition for at least 6 months after enrollment
- Age less than 18 years but greater than 4 weeks chronological age or 40 weeks estimated gestational age, whichever is greater
- Stable parenteral nutrition cycling with at least 4 hours off per day suitable for home management
- Presence of a tunneled central venous catheter, port-a-catheter, or PICC
- Clinically stable for at least 4 weeks with no acute medical comorbidities
- Minimum catheter dwell time of 4 consecutive hours daily
- Care provider willing to give informed consent and comply with study protocol
You will not qualify if you...
- Use of a temporary central venous catheter (jugular or femoral) or peripheral catheter
- Receiving long-term parenteral nutrition not due to primary intestinal disorder (e.g., oncology patients or premature neonates due to intestinal immaturity)
- Known allergy or reaction to EDTA
- Pregnancy or nursing
- Participation in another investigational device or drug trial within 30 days before enrollment (unless approved by trial investigators)
- Severe coagulopathy (platelets under 50,000 or INR over 1.5)
- Diagnosis of immunodeficiency disorder
- Unstable medical condition requiring hospital admission
- Received antibiotic treatment for catheter-related bloodstream infection within last 14 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Not Yet Recruiting
3
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
4
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
5
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
6
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
7
Cook Children's Health Care System
Fort Worth, Texas, United States, 76104
Actively Recruiting
8
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
J
Joanne Greco
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here