KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure

Recruiting N/A Interventional Study
Pediatric Intestinal Failure
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
4 Weeks – 18
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
124 (estimated)
Sponsor
SterileCare Inc. · Industry
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patients managed by the intestinal rehabilitation program at one of the participating centers. 2. Diagnosis of intestinal failure defined as need for PN support for \>60 days in previous 74 days for primary intestinal disease (short bowel syndrome, primary motility disorder, …
Contacts

Joanne Greco

6472006232

jgreco@sterilecareinc.com

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