A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters

Summary

This was a Phase III, randomized, double-blind, placebo-controlled study that was conducted at 24 centers in the United States and Canada. 100 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were randomly assigned in a 1:1 ratio to receive an initial dose of either placebo (Arm A) or tenecteplase (Arm B).

Timeline

Start

2006-11

Primary completion

2008-06

Completion

—

Outcome

Met primary endpoint

paper catheter function was restored to 30 patients (60%) in the TNK-TNK-PBO arm and 11 patients (23%) in the PBO-TNK-TNK arm PMID 21111365 ↗

paper for a treatment difference of 37 percentage points (95% confidence interval 18-55; P = .0002). PMID 21111365 ↗

Publications

• Gabrail N, Sandler E, Charu V, Anas N, Lim E, Blaney M, Ashby M, Gillespie BS, Begelman SM. TROPICS 1: a phase III, randomized, double-blind, placebo-controlled study of tenecteplase for restoration of function in dysfunctional central venous catheters. J Vasc Interv Radiol. 2010 Dec;21(12):1852-8. doi: 10.1016/j.jvir.2010.09.002.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenecteplase	Protein / enzyme biologic	2 mg	Other

Indications

No indication recorded.