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NCT05879835 · ClinicalTrials.gov registry record · NA
KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
A NA study of Pediatric Intestinal Failure, sponsored by SterileCare.
- Recruiting
- Registry status
- NA
- Development phase
- 124
- Enrollment target
- 8
- Study locations
NCT05879835: Recruiting NA study of Pediatric Intestinal Failure, sponsored by SterileCare.
NCT05879835 is a NA study of Pediatric Intestinal Failure that is actively recruiting participants, run by SterileCare. The registered enrollment target is 124 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05879835, a NA study of Pediatric Intestinal Failure, is actively recruiting participants, sponsored by SterileCare.
- RECRUITING
- Registry status
- NA
- Development phase
- 124 participants
- Enrollment target
- 8
- Study locations
Study 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).
Primary Outcome
Occlusion is defined as requiring chemical or surgical intervention to restore patency. Occlusion rates will be pooled for each study arm and reported per 1000 catheter days.
Conditions Studied
Interventions
- DEVICE KiteLock 4% Sterile Catheter Lock Solution
- DEVICE Heparin Lock Solution
Study Locations (8)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Massachusetts
- Boston Children's Hospital - Boston
Nebraska
- University of Nebraska Medical Center - Omaha
New York
- Columbia University Irving Medical Center - New York
North Carolina
- Duke University Medical Center - Durham
Texas
- Cook Children's Health Care System - Fort Worth
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2024-06-21 |
| Est. Completion | 2026-06 |
| Phase | NA |
What NCT05879835 shows while recruiting
NCT05879835 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Pediatric Intestinal Failure appearing as the primary indexed condition, and to 2 interventions - of which KiteLock 4% Sterile Catheter Lock Solution is the first listed.
NCT05879835 lists 8 locations in 7 states (Ohio, Massachusetts, Nebraska).
Frequently Asked Questions
What is clinical trial NCT05879835 about?
NCT05879835 is a clinical study titled "KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure". 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).
What is the current status of trial NCT05879835?
This trial is currently recruiting. It is a NA study. The enrollment target is 124 participants. The study started on 2024-06-21. Estimated completion is 2026-06.
What conditions does trial NCT05879835 study?
This clinical trial studies the following conditions: Pediatric Intestinal Failure.
What interventions are being tested in trial NCT05879835?
The interventions under investigation include: KiteLock 4% Sterile Catheter Lock Solution (DEVICE), Heparin Lock Solution (DEVICE).
Who is sponsoring clinical trial NCT05879835?
This trial is sponsored by SterileCare, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05879835 being conducted?
This trial has 8 study locations across Massachusetts, Nebraska, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pediatric Intestinal Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05879835's enrollment target sits among peer trials
124 758th of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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