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Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04559334
Recruitment Status : Enrolling by invitation
First Posted : September 22, 2020
Last Update Posted : February 10, 2022
Sponsor:
Collaborator:
SterileCare Inc.
Information provided by (Responsible Party):
Mark Puder, Boston Children's Hospital

Brief Summary:
In this research study we want to learn more about a study drug, tetrasodium sodium EDTA (Kitelock™) for maintaining the patency (blood flow) through a central venous catheter. Catheter occlusions such as blood clots have been shown to increase the risk of central line-associated bloodstream infection (CLABSI). This treatment consists of instilling a daily a dose of a solution , similar to heparin or saline lock flushes, into the catheter when it is not in use. The aim is to prevent CLABSI without increasing complications such as catheter breakage.

Condition or disease Intervention/treatment Phase
Central Line Complication Central Line-associated Bloodstream Infection (CLABSI) Device: Tetrasodium EDTA Catheter Lock Solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Assessment of the effect of treatment will be based on a compassionate use study of parenterally administered 4% T-EDTA lock solution (KiteLock™ 4% Sterile Catheter Lock Solution) to determine safety and preliminary efficacy in the prevention of (1) thrombolytic occlusions, (2) catheter breakage and (3) CLABSI events. Each patient will serves as their own control with the catheter history 12 months' prior for each patient pre KiteLock ™ use (i.e., breakages, occlusions, CLABSIs) being compared with KiteLock ™ experience.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Actual Study Start Date : December 21, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
open label
All participants will receive Tetrasodium EDTA Catheter Lock Solution (KiteLock™ 4% Sterile Catheter Lock Solution)
Device: Tetrasodium EDTA Catheter Lock Solution
KiteLock™ 4% Sterile Catheter Lock Solution is a single use, clear, colorless and sterile solution. It is free of preservatives, alcohol and latex and is non-pyrogenic. KiteLock™ 4% is an aqueous solution containing a mixture of edetate tetrasodium and edetate trisodium. The solution composition is equivalent to 28 mg/mL edetate. EDTA is a known chelator. This means it has an affinity for metals and elements such as calcium. As a primary mechanism of action, it acts as a space occupying solution to prevent blood from entering the tip of the catheter when the catheter is not in use. As a secondary mechanism of action, it acts as an in vitro anticoagulant. This dual action decreases the risk of clot formation, consequently thrombolytic occlusions and by extension decreases the risk of CLABSI.
Other Name: KiteLock™ 4% Sterile Catheter Lock Solution




Primary Outcome Measures :
  1. The Number of participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: through study completion, an average of 1 year ]
    The number of treatment-related events as assessed by CTCAE v4.0 will be tracked for all study participants receiving 4% T-EDTA lock solution

  2. The Number of Participants with Catheter Occlusions [ Time Frame: through study completion, an average of 1 year ]
    The number of participants with catheter occlusions based on thrombolytic usage or need for catheter removal as assessed during clinical visits and admissions to the hospital or emergency room.

  3. The Number of Participants with Catheter Breaks [ Time Frame: through study completion, an average of 1 year ]
    The number of catheter breaks requiring catheters to be repaired or replaced will be collected based on emergency room and hospital records.


Secondary Outcome Measures :
  1. The Number of Central Line Associated Bloodstream Infections (CLABSIs) [ Time Frame: through study completion, an average of 1 year ]
    The number and pattern CLABSIs in participants will be assessed based on emergency room and hospital records.



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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Presence of a tunneled central venous catheter or peripherally inserted central catheter (PICC) for administration of PN or intravenous hydration fluids to treat intestinal failure
  2. Patients aged 3 months to 18 years old inclusive
  3. Minimum patient weight of at least 5 kilograms
  4. History of at least one thrombolytic occlusion and/or CLABSI event
  5. Signed patient informed consent
  6. Clinically stable for at least 4 weeks with no acute medical co-morbidities

Exclusion Criteria:

  1. Pregnancy or nursing mother
  2. Enrollment in any other clinical trial involving an investigational agent (unless approved by the principal investigators of the other trial)
  3. The parent or guardian or child unwilling to provide consent or assent
  4. Clinical instability such as the following:

    • Acute pulmonary edema
    • Acute myocardial infarction
    • Acute stroke
    • Acute thromboembolism
    • Metabolic acidosis
    • Sepsis
    • Coagulopathy with prolonged activated partial thromboplastin time (aPTT) or international normalized ratio (INR)
    • Severe hypoglycemia
  5. Subjects who are hypersensitive or allergic to EDTA
  6. Active therapy with long-term anti-microbial agents, such as taurolidine (not including patients receiving intermittent antimicrobial treatment for small intestinal bacterial overgrowth)
  7. A compromised catheter defined as one which has been repaired several times.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04559334


Locations
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United States, Massachusetts
Childrens's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
SterileCare Inc.
Investigators
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Principal Investigator: Mark Puder, MD, PhD Boston Children's Hospital
Publications:

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Responsible Party: Mark Puder, Senior Associate, Department of Surgery. Professor of Surgery, Harvard Medical School, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT04559334    
Other Study ID Numbers: IRB-P00035952
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Upon completion of the the study, the results will be published in a peer reviewed journal - including incidence of catheter occlusions, catheter breaks, and CLABSI events.

Upon request we will share study protocol and supporting materials (consent, how to obtain device)

Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: To be determined.
Access Criteria: To be determined.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Mark Puder, Boston Children's Hospital:
central venous catheter
CLABSI
catheter occlusion
vascular access device
catheter patency
intestinal failure
parenteral nutrition
Additional relevant MeSH terms:
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Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Pharmaceutical Solutions