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| Name | Class |
|---|---|
| Dicentra Inc. | INDUSTRY |
| Meditrial SrL | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KiteLock 4% Sterile Catheter Lock Solution | Experimental | 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. |
|
| Heparin Lock Solution | Active Comparator | Heparin lock solution will be administered daily per investigator judgement, given its significant clinical risk in the youngest/smallest/vulnerable subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KiteLock 4% Sterile Catheter Lock Solution | Device | KiteLockâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 52 weeks |
| Incidence of breakage, removal, or reinsertion of catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects requiring hospital admission related to catheter complications | Proportion shall be reported for each study arm. | 52 weeks |
| Length of stay for hospitalization related to catheter complications |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joanne Greco | Contact | 6472006232 | jgreco@sterilecareinc.com |
| Name | Affiliation | Role |
|---|---|---|
| Paul Wales, MD | Cincinnati Children's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32770561 | Background | Quirt J, Belza C, Pai N, Clause RF, Markovic F, Wong-Sterling S, Avitzur Y, Wales PW. Reduction of Central Line-Associated Bloodstream Infections and Line Occlusions in Pediatric Intestinal Failure Patients Receiving Long-Term Parenteral Nutrition Using an Alternative Locking Solution, 4% Tetrasodium Ethylenediaminetetraacetic Acid. JPEN J Parenter Enteral Nutr. 2021 Aug;45(6):1286-1292. doi: 10.1002/jpen.1989. Epub 2020 Aug 30. |
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Multisite, randomized, open-label, 2-arm parallel-group superiority trial
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| Heparin Lock Solution | Device | Nonpyrogenic, hypertonic preparation of heparin sodium injection, USP with sodium chloride in water for injection. |
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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. |
| 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. | 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 | 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. | 52 weeks |
Length of hospital stay shall be reported in days. Mean shall be reported for each study arm
| 52 weeks |
| University of Nebraska Medical Center | Not yet recruiting | Omaha | Nebraska | 68198 | United States |
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| Nyph/Cumc | Recruiting | New York | New York | 10032 | United States |
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| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
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| Cook Children's Health Care System | Recruiting | Fort Worth | Texas | 76104 | United States |
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| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
|
| ID | Term |
|---|---|
| D000090124 | Intestinal Failure |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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