Randomized, double-blind, placebo-controlled, interventional phase IV investigation to assess the efficacy and safety of r-hirudin gel (1120I.U) in patients with hematomas

Abstract

Essentials Efficacy and safety data on recombinant hirudin gels for the treatment of hematomas is limited. We assessed the clinical efficacy of a topical r-hirudin gel in 199 patients with hematomas. Treated patients exhibited significant reductions in hematoma size and flare within 16 days. r-hirudin gel treatment induces a complete resolution of hematomas and associated edema in 98%, and 99% of patients, respectively. Background: Hirudin is the most potent direct thrombin inhibitor, and recombinant forms are routinely used in anticoagulation therapy. Recombinant hirudin gels are commercially available for the treatment of hematomas and associated symptoms. Objectives: To assess the efficacy and safety of a topically administered recombinant hirudin gel in patients with hematomas. Patients/Methods: This double-blind, placebo-controlled, phase IV investigation recruited patients presenting with at least one hematoma. Subjects were randomly assigned (1:1) recombinant hirudin gel (1120 IU/100 g) or a placebo, administered 2-3 times daily for 16 days. Changes in hematoma size, flare, and the proportion of patients achieving complete resolution of hematomas and associated edemas were investigated. Results: By study end, a greater proportion of subjects in the treatment group achieved a complete resolution of hematomas versus placebo (98.0% vs 71.9%; P