KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
Start Date
6/21/2024
Completion Date
6/1/2027
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).
Detailed Description
A total of 124 (62 per arm) will be enrolled into the study. Screening and informed consent (and assent if applicable) will be obtained prior to study procedures. The baseline assessment will be completed at recruitment to the study. Once the baseline assessment is complete and eligible subjects are randomized, the study drug will be dispensed per protocol. The study follow-up period will be 52 weeks. Four follow-up clinical in-person visits will occur at 2,12, 28, 40 and 52 weeks. Visits will be conducted by physicians or nurse practitioners. The study visits will assess general status, study bloodwork, adverse events, catheter patency, alteplase use, infection assessment, catheter integrity, and provide investigational product. Telephone follow up will occur on day-3 of intervention, and once per 4 weeks, as well as in the event of outpatient care/hospital admission, or safety event. Subject daily diaries will be utilized for detailed monitoring. Diary recordings will include adverse events, including occlusive events, and any subject specific details (e.g. dwell times, heparin flushing vs. aspiration) or issues in the delivery of the study locking solutions.
Eligibility Criteria
Age Range: No minimum to 18 years
Interventions
KiteLock 4% Sterile Catheter Lock Solution
Heparin Lock Solution
Conditions
Locations
Boston Children's Hospital
Boston, Massachusetts 02115
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Nyph/Cumc
New York, New York 10032
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
Cook Children's Health Care System
Fort Worth, Texas 76104
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States