Rheumatoid Arthritis Clinical Trials

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

NCT04559334

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.

Central Line ComplicationCentral Line-associated Bloodstream Infection (CLABSI)

Boston Children's Hospital15 participantsStarted Dec 2020

Boston, Massachusetts, United States

Active Not Recruiting

A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT

NCT04015128

This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 50 subjects will be enrolled. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System. Total duration of enrollment, 12 month follow-up and analysis is expected to take 25 months. The clinical investigation has been designed to follow the surgeon's standard of care for femur fractured subjects, in addition to a 12 month follow-up visit. The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the Lower Extremity Measure (LEM). Confirmation of efficacy/performance at 12 months will be based on an equal or greater (non-inferior) LEM score result of the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System compared to the T2 Femur benchmark literature.

Femoral Fracture

Stryker Trauma and Extremities66 participantsStarted Sep 2019

Sartell, Minnesota, United States • Reno, Nevada, United States • New York, New York, United States +3 more locations

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

A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT

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