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.
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Randomized Controlled Trial Clinical Trial
Activation of fibrinolysis in the pericardial cavity after cardiopulmonary bypass.
Aprotinin is frequently administered systemically in patients undergoing cardiopulmonary bypass to preserve platelet function and ameliorate excessive activation of fibrinolysis. More recently, aprotinin topically applied in the pericardial cavity was also found to improve postoperative blood loss. However, platelet activation was not reduced locally during surgery. ⋯ Furthermore, evidence was provided that topically applied aprotinin reduces not only the local fibrinolytic activity but also the postoperative blood loss significantly by 33% which demonstrates the clinical relevance. The local activation of fibrinolysis seems to play an important role in blood loss after cardiopulmonary bypass. Therefore in fibrinolysis and blood coagulation the surgeon should not only consider what happens in the systemic circulation but also on a local level.