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

Unlabelled Box BackgroundHirudin 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. ObjectivesTo assess the efficacy and safety of a topically administered recombinant hirudin gel in patients with hematomas. Patients/MethodsThis 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. ResultsBy 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 < .001) and edemas (99% vs 50%; P < .001). Patients in the recombinant hirudin group exhibited a marginally larger, yet significant, reduction in mean hematoma size versus placebo (99.9% vs 96.6%; P < .001) and flare (93.6% vs 78.6%; P < .001). Median time to hematoma resolution for the recombinant hirudin and placebo administered cohorts was 8 and 16 days, respectively (P < .001). No adverse events were reported for the recombinant hirudin cohort. ConclusionsTopical recombinant hirudin is an effective, safe, and well tolerated intervention for the symptomatic treatment of hematomas. This trial was registered at www.clinicaltrials.gov as NCT01960569.