Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
SUSPENDED
NCT04559334
NA

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

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

3 Months - 18 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2020-12-21

Completion Date

2027-12-31

Last Updated

2026-04-15

Healthy Volunteers

No

Interventions

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.

Locations (1)

Childrens's Hospital Boston

Boston, Massachusetts, United States