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

RecruitingNAAges 4 Weeks - 18 YearsAllSterileCare Inc.
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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, mucosal enteropathy). 3. Expectation of the treating physician that the patient will require PN for at least 6 months following enrollment. 4. Age less than 18 years at diagnosis but greater than 4 weeks chronological age or 40 weeks estimated gestational age, whichever is greater. 5. Stable TPN cycling (4 hours off TPN minimum per day) enabling home TPN management 6. Presence of a tunneled central venous catheter (CVC), port-a-catheter, or peripherally inserted central catheter (PICC). 7. Clinical stability for at least 4 weeks and no acute medical comorbidities. 8. A minimum dwell time of 4 consecutive hours daily. 9. Care provider willing to provide informed consent to participate in the trial and willing to comply with randomization and study protocol. Exclusion Criteria: 1. A temporary CVC (jugular or femoral) or peripheral catheter. 2. Patients receiving long-term PN, but not due to a primary intestinal disorder (i.e., oncology patients or premature neonates on PN due to intestinal immaturity). 3. Known hypersensitivity, allergy, or reaction to EDTA. 4. Pregnancy or nursing mother. 5. Participation in another investigational device or drug trial within 30 days prior to enrollment (unless approved by the principal investigators of the trial). 6. Severe coagulopathy (platelets \<50,000, or INR \> 1.5). 7. Diagnosis of immunodeficiency disorder. 8. Unstable medical condition requiring hospital admission 9. Received antibiotic therapy for CLABSI within last 14 days.
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What it tests

  • KiteLock 4% Sterile Catheter Lock Solution
  • Heparin Lock Solution
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Where

8 sites
Boston Children's Hospital
Boston, United States
University of Nebraska Medical Center
Omaha, United States
Nyph/Cumc
New York, United States
Duke University Medical Center
Durham, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, United States
Nationwide Children's Hospital
Columbus, United States
Cook Children's Health Care System
Fort Worth, United States
Seattle Children's Hospital
Seattle, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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