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
|Condition or disease||Intervention/treatment||Phase|
|Central Line Complication Central Line-associated Bloodstream Infection (CLABSI)||Device: Tetrasodium EDTA Catheter Lock Solution||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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)|
|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|
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
- 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
- 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.
- 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.
- 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.
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
|United States, Massachusetts|
|Childrens's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Mark Puder, MD, PhD||Boston Children's Hospital|