An interventional study of KiteLock 4% Sterile Catheter Lock Solution and Heparin Lock Solution in Pediatric Intestinal Failure, sponsored by SterileCare Inc.. Recruiting at 8 sites in United States. Open to participants aged 4 Weeks to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by SterileCare Inc. · Not applicable, Interventional, and Prevention
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).
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.
64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.
This study's planned enrollment of 124 is above the median of 38 across 42 interventional studies indexed under Intestinal Failure.
Browse Intestinal Failure studies →This is the only study on the registry with SterileCare Inc. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4% Tetrasodium EDTA lock solution (KiteLock 4% Sterile Catheter Lock Solution; SterileCare Inc., Canada) will be administered 4-24 hours daily while the patient is cycled off their PN, as per site standard operating procedures.
Device: KiteLock 4% Sterile Catheter Lock Solution
Heparin lock solution will be administered daily per investigator judgement, given its significant clinical risk in the youngest/smallest/vulnerable subjects.
Device: Heparin 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.
Nonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection.
Incidence of catheter occlusions
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.
Time frame: 52 weeks
Incidence of Central Line-Associated Blood Stream Infections (CLABSI)
CLABSI is defined per the Centers for Disease Control-National Healthcare Safety Network (CDC-NSHN) definition. CLABSI rates will be pooled for each study arm and reported per 1000 catheter days.
Time frame: 52 weeks
Incidence of breakage, removal, or reinsertion of catheter
Breakage of the catheter line, surgical removal of the line or reinsertion of the line into the vein will be recorded. Event rates will be pooled for each study arm and reported per 1000 catheter days.
Time frame: 52 weeks
Incidence of central venous thrombosis
Central venous thrombosis shall be clinically diagnosed by investigators, including the collection of brain imaging. Central Venous Thrombosis rates will be pooled for each study arm and reported per 1000 catheter days.
Time frame: 52 weeks
Proportion of subjects with development of Intestinal failure-associated liver disease (IFALD)
IFALD is defined as (cholestasis defined as conjugated bilirubin \>2mg/dL, advanced IFALD defined as conjugated bilirubin \>6mg/dL) sustained for \>2 weeks in absence of sepsis. Proportion shall be reported for each study arm
Time frame: 52 weeks
Incidence of lock-related Serious Adverse Events (SAEs)
SAEs are defined per Good Clinical Practice. SAE rates will be pooled for each study arm and reported per 1000 catheter days.
Time frame: 52 weeks
Proportion of subjects requiring hospital admission related to catheter complications
Proportion shall be reported for each study arm.
Time frame: 52 weeks
Length of stay for hospitalization related to catheter complications
Length of hospital stay shall be reported in days. Mean shall be reported for each study arm
Time frame: 52 weeks
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