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

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 < .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. CONCLUSIONS: Topical recombinant hirudin is an effective, safe, and well tolerated intervention for the symptomatic treatment of hematomas. This trial was registered at http://www.clinicaltrials.gov as NCT01960569.