Safety Outcomes

Episodes of major bleeding occurred in 13/91 (14.3%) of patients in this meta-analysis (risk for major bleeding per treatment day 1.3%). aPTT ratios above 2.5 were associated with an increased risk of bleeding, and bleeding rates were significantly lower in patients with aPTT <60 s (p < 0.001). Nearly all patients with bleeding complications had impaired renal function. Antihirudin antibodies were detected in 26 of the 66 (39.4%) evaluable patients. There were no differences in adverse events or outcomes between patients with and without antihirudin antibodies. No anaphylaxis was observed.

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