Title: A dose-finding clinical trial of staphylokinase SY162 in patients with long-term venous access catheter thrombotic occlusion
Authors: Verhamme, Peter ×
Goossens, Godelieve
Maleux, Geert
Collen, Desire
Stas, Marguerite #
Issue Date: Aug-2007
Publisher: Kluwer Academic Publishers
Series Title: Journal of Thrombosis and Thrombolysis vol:24 issue:1 pages:1-5
Abstract: BACKGROUND: We investigated the safety and efficacy of several dosing regimens of catheter-directed staphylokinase (SY162) bolus administration for the treatment of long-term venous access catheter occlusion. METHODS: This open-label, ascending dose study enrolled 24 subjects. Three doses of SY162 were evaluated in three cohorts (0.15 mg, 0.3 mg and 0.45 mg) with eight subjects each. 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. Cathetergram was repeated to assess thrombus resolution. RESULTS: Complete restoration of catheter withdrawal function was observed in 2 (25%), 1 (13%) and 7 (88%) subjects after the first bolus in the first, second and third cohort respectively and in 4 (50%), 7 (88%) and 7 (88%) patients after the second administration of SY162. There were no bleeding complications nor other adverse events related to SY162. CONCLUSIONS: The doses tested in this trial were well tolerated and safe. A dose-response effect within the dose range tested was observed. A 2ml bolus injection of 0.45 mg SY162 resulted in optimal efficacy after 30 min.
ISSN: 0929-5305
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Academic Centre for Nursing and Midwifery
Surgical Oncology
Molecular and Vascular Biology
× corresponding author
# (joint) last author

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