Effects of thrombomodulin alfa on hemostatic parameters in disseminated intravascular coagulation: Post hoc analysis of a phase 3 randomized controlled trial
| Autor: | Akio Hirayama, Naoki Aikawa, Shuji Shimazaki, Hidehiko Saito, Goichi Honda, Yasuhiro Yamamoto, Ikuro Maruyama, Takashi Ito |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment Population heparin Thrombomodulin Gastroenterology protein C Internal medicine Fibrinolysis medicine Diseases of the blood and blood-forming organs education disseminated intravascular coagulation Disseminated intravascular coagulation education.field_of_study medicine.diagnostic_test business.industry Antithrombin Hematology Heparin thrombomodulin medicine.disease thrombin Thrombomodulin Alfa Original Articles ‐ Hemostasis Original Article RC633-647.5 business medicine.drug Partial thromboplastin time |
| Zdroj: | Research and Practice in Thrombosis and Haemostasis, Vol 4, Iss 7, Pp 1141-1149 (2020) Research and Practice in Thrombosis and Haemostasis |
| ISSN: | 2475-0379 |
| Popis: | Background The efficacy and safety of thrombomodulin alfa (TM-α), a cofactor protein promoting thrombin-mediated protein C activation, have been examined in a phase 3 randomized, double-blinded, parallel-group trial in Japan. We have previously reported that TM-α is noninferior to heparin for the resolution of disseminated intravascular coagulation (DIC). Objective To investigate the basis for the efficacy of TM-α in the phase 3 clinical trial in Japan through post hoc analysis of coagulation and fibrinolysis parameters. Patients/methods The 227 patients of the full analysis set population described in the original phase 3 trial in Japan were included in this analysis. Changes in parameters between before and after TM-α or heparin administration in each of the two patient groups, with underlying diseases of either hematologic malignancy or infection, were studied separately and results were compared between TM-α and heparin treatment groups in a post hoc manner. Results TM-α administration did not prolong activated partial thromboplastin time but significantly decreased thrombin-antithrombin complex levels compared with heparin treatment. TM-α administration reduced consumption of endogenous anticoagulants such as antithrombin and protein C by DIC, compared with the heparin group. DIC scores were decreased in both TM-α and heparin groups during the 6-day treatment. Conclusion TM-α can alleviate intravascular coagulation and consumption of anticoagulants without extending coagulation times. This may be associated with the relatively low risk of bleeding during TM-α treatment. |
| Databáze: | OpenAIRE |
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