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

NARecruitingINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

June 21, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Pediatric Intestinal Failure
Interventions
DEVICE

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.

DEVICE

Heparin Lock Solution

Nonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection.

Trial Locations (5)

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

68198

NOT_YET_RECRUITING

University of Nebraska Medical Center, Omaha

76104

RECRUITING

Cook Children's Health Care System, Fort Worth

98105

RECRUITING

Seattle Children's Hospital, Seattle

02115

RECRUITING

Boston Children's Hospital, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Dicentra Inc.

INDUSTRY

collaborator

Meditrial SrL

INDUSTRY

lead

SterileCare Inc.

INDUSTRY

NCT05879835 - KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children with Intestinal Failure | Biotech Hunter | Biotech Hunter