BACKGROUND: Microplasmin, a truncated form of plasmin, degrades fibrin and reacts with the circulating inhibitor alpha(2)-antiplasmin. We investigated the safety and efficacy of intra-catheter microplasmin bolus administration for the restoration of catheter function in long-term venous access catheter thrombosis. METHODS: This open-label, ascending-dose, pilot study enrolled 31 subjects. Two doses of microplasmin were evaluated, (5 mg and 8 mg) administered via a 2 ml intra-catheter bolus injection in 10 and 21 patients respectively. Catheter function was evaluated 30 min after the first bolus administration. In case of incomplete catheter function restoration, a second bolus was administered with reassessment of catheter function 30 min thereafter. RESULTS: After the first bolus, complete restoration of catheter withdrawal function was observed in 5 out of 10 (50%) and 14 of out 21 (66%) subjects treated with 5 mg and 8 mg respectively and in 8 out of 10 (80%) and 18 out of 21 (86%) subjects after a second administration of microplasmin. No bleeding complications nor other adverse events were related to microplasmin. CONCLUSIONS: In this pilot trial, microplasmin restored catheter function in a safe and effective way.
BACKGROUND: Microplasmin, a truncated form of plasmin, degrades fibrin and reacts with the circulating inhibitor alpha(2)-antiplasmin. We investigated the safety and efficacy of intra-catheter microplasmin bolus administration for the restoration of catheter function in long-term venous access catheter thrombosis. METHODS: This open-label, ascending-dose, pilot study enrolled 31 subjects. Two doses of microplasmin were evaluated, (5 mg and 8 mg) administered via a 2 ml intra-catheter bolus injection in 10 and 21 patients respectively. Catheter function was evaluated 30 min after the first bolus administration. In case of incomplete catheter function restoration, a second bolus was administered with reassessment of catheter function 30 min thereafter. RESULTS: After the first bolus, complete restoration of catheter withdrawal function was observed in 5 out of 10 (50%) and 14 of out 21 (66%) subjects treated with 5 mg and 8 mg respectively and in 8 out of 10 (80%) and 18 out of 21 (86%) subjects after a second administration of microplasmin. No bleeding complications nor other adverse events were related to microplasmin. CONCLUSIONS: In this pilot trial, microplasmin restored catheter function in a safe and effective way.
Authors: V J Marder; K Landskroner; V Novokhatny; T P Zimmerman; M Kong; J J Kanouse; G Jesmok Journal: Thromb Haemost Date: 2001-09 Impact factor: 5.249
Authors: Curtis A Lewis; Timothy E Allen; Dana R Burke; John F Cardella; Steven J Citron; Patricia E Cole; Alain T Drooz; Elizabeth A Drucker; Ziv J Haskal; Louis G Martin; A Van Moore; Calvin D Neithamer; Steven B Oglevie; Kenneth S Rholl; Anne C Roberts; David Sacks; Orestes Sanchez; Anthony Venbrux; Curtis W Bakal Journal: J Vasc Interv Radiol Date: 2003-09 Impact factor: 3.464
Authors: William D Haire; Steven R Deitcher; Kathleen M Mullane; Michael R Jaff; Carolyn M Firszt; Gregory A Schulz; Debra M Schuerr; Lewis B Schwartz; Tamyra L Mouginis; R Phillip Barton Journal: Thromb Haemost Date: 2004-09 Impact factor: 5.249
Authors: Steven R Deitcher; Walter D Funk; James Buchanan; Shouchun Liu; Michael D Levy; Christopher F Toombs Journal: Expert Opin Biol Ther Date: 2006-12 Impact factor: 4.388
Authors: Charles P Semba; Steven R Deitcher; Xin Li; Laura Resnansky; Tri Tu; Edward R McCluskey Journal: J Vasc Interv Radiol Date: 2002-12 Impact factor: 3.464
Authors: Petr Svoboda; R Philip Barton; Olga L Barbarash; Alexey A Butylin; Brian R Jacobs; Jan Lata; William D Haire; Michael R Jaff; Carolyn M Firszt; Tamyra L Mouginis; Debra M Schuerr; Gregory A Schulz; Lewis B Schwartz; Mohamed A El-Shahawy Journal: Crit Care Med Date: 2004-10 Impact factor: 7.598
Authors: Christophe Dommke; Oliver Turschner; Jean-Marie Stassen; Frans Van de Werf; H Roger Lijnen; Peter Verhamme Journal: J Thromb Thrombolysis Date: 2010-07 Impact factor: 2.300