Thromb Haemostasis
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Randomized Controlled Trial Multicenter Study Clinical Trial
Recombinant urokinase for restoration of patency in occluded central venous access devices. A double-blind, placebo-controlled trial.
The interval occlusion of central venous access devices (CVADs) remains a significant clinical problem, often requiring re-intervention for catheter exchange or replacement. The purpose of this Phase 3, multi-center, double-blinded study was to test the hypothesis that instillation of recombinant urokinase (r-UK) 5000 IU/ml is superior to placebo in restoring total catheter patency to an unselected cohort of occluded CVADs. After obtaining informed consent, adult and pediatric patients with occluded, non-hemodialysis CVADs of any duration or type were randomized (2 : 1) to receive either r-UK 5000 IU/ml or placebo instilled into all occluded lumens of their catheter. ⋯ There were no major hemorrhagic events within 72 hr after up to four r-UK instillations, and the incidence of non-hemorrhagic events was similar among the r-UK and placebo groups. In conclusion, r-UK is superior to placebo in restoring total catheter patency to occluded CVADs. In patients with occluded CVADs, intra-catheter thrombolysis can restore patency and may obviate the need for catheter replacement.