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
| Autor: | Ahmed M. Zaghloul, Yasser Kandil, Ahmed El Araby, Hani El-Mowafi |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Hirudin
Placebo administration 03 medical and health sciences 0302 clinical medicine Hematoma Edema hirudins Medicine 030212 general & internal medicine topical Adverse effect Original Articles: Haemostasis business.industry Antithrombin hematoma Hematology medicine.disease antithrombin trauma surgical procedures operative 030228 respiratory system Direct thrombin inhibitor Anesthesia Cohort Original Article medicine.symptom business medicine.drug |
| Zdroj: | Research and Practice in Thrombosis and Haemostasis |
| ISSN: | 2475-0379 |
| DOI: | 10.1002/rth2.12049 |
| Popis: | 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 www.clinicaltrials.gov as NCT01960569. |
| Databáze: | OpenAIRE |
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