Recombinant soluble human thrombomodulin (thrombomodulin alfa) in the treatment of neonatal disseminated intravascular coagulation. 2014

Akira Shirahata, and Jun Mimuro, and Hoyu Takahashi, and Isao Kitajima, and Hajime Tsuji, and Yutaka Eguchi, and Tadashi Matsushita, and Masahiro Kajiki, and Goichi Honda, and Yoichi Sakata
University of Occupational and Environmental Health, Japan, Kitakyushu, Fukuoka, Japan, a-shirahata@kitakyu-hp.or.jp.

Recombinant soluble human thrombomodulin (TM-α) has been shown to be useful in the treatment of disseminated intravascular coagulation (DIC) in a heparin-controlled study and has been available for clinical use in Japan since 2008. However, data on its use for neonatal DIC have not been reported from any clinical studies, so efficacy and safety were analyzed in 60 neonatal DIC patients identified in post-marketing surveillance. The DIC resolution rate as of the day after last administration of TM-α was 47.1 %, and the survival rate at 28 days after last administration was 76.7 %. Hemostatic test result profiles revealed decreased levels of fibrin/fibrinogen degradation products and increased platelet counts and antithrombin activity. Incidences of adverse drug reactions, bleeding-related adverse drug reactions, and bleeding-related adverse events were 6.7, 6.7, and 16.7 %, respectively, with no significant differences between neonatal, pediatric (excluding neonates), and adult DIC patients. CONCLUSIONS This surveillance provided real-world data on the safety and effectiveness of TM-alpha in the treatment of neonatal DIC in general practice settings.

UI MeSH Term Description Entries
D007231 Infant, Newborn An infant during the first 28 days after birth. Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
D011358 Product Surveillance, Postmarketing Surveillance of drugs, devices, appliances, etc., for efficacy or adverse effects, after they have been released for general sale. Drug Surveillance, Postmarketing,Evaluation Studies, Postmarketing,Postmarketing Product Surveillance,Product Surveillance, Post-Marketing,Drug Surveillances, Postmarketing,Evaluation Study, Postmarketing,Post-Marketing Product Surveillance,Post-Marketing Product Surveillances,Postmarketing Drug Surveillance,Postmarketing Drug Surveillances,Postmarketing Evaluation Studies,Postmarketing Evaluation Study,Postmarketing Product Surveillances,Product Surveillance, Post Marketing,Product Surveillances, Post-Marketing,Product Surveillances, Postmarketing,Studies, Postmarketing Evaluation,Study, Postmarketing Evaluation,Surveillance, Post-Marketing Product,Surveillance, Postmarketing Drug,Surveillance, Postmarketing Product,Surveillances, Post-Marketing Product,Surveillances, Postmarketing Drug,Surveillances, Postmarketing Product
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D004211 Disseminated Intravascular Coagulation A disorder characterized by procoagulant substances entering the general circulation causing a systemic thrombotic process. The activation of the clotting mechanism may arise from any of a number of disorders. A majority of the patients manifest skin lesions, sometimes leading to PURPURA FULMINANS. Consumption Coagulopathy,Coagulation, Disseminated Intravascular,Disseminated Coagulation, Intravascular,Intravascular Coagulation, Disseminated,Intravascular Disseminated Coagulation,Coagulation, Intravascular Disseminated,Coagulations, Disseminated Intravascular,Coagulations, Intravascular Disseminated,Coagulopathies, Consumption,Coagulopathy, Consumption,Consumption Coagulopathies,Disseminated Coagulations, Intravascular,Disseminated Intravascular Coagulations,Intravascular Coagulations, Disseminated,Intravascular Disseminated Coagulations
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D015996 Survival Rate The proportion of survivors in a group, e.g., of patients, studied and followed over a period, or the proportion of persons in a specified group alive at the beginning of a time interval who survive to the end of the interval. It is often studied using life table methods. Cumulative Survival Rate,Mean Survival Time,Cumulative Survival Rates,Mean Survival Times,Rate, Cumulative Survival,Rate, Survival,Rates, Cumulative Survival,Rates, Survival,Survival Rate, Cumulative,Survival Rates,Survival Rates, Cumulative,Survival Time, Mean,Survival Times, Mean,Time, Mean Survival,Times, Mean Survival
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D018180 Thrombomodulin A cell surface glycoprotein of endothelial cells that binds thrombin and serves as a cofactor in the activation of protein C and its regulation of blood coagulation.

Related Publications

Akira Shirahata, and Jun Mimuro, and Hoyu Takahashi, and Isao Kitajima, and Hajime Tsuji, and Yutaka Eguchi, and Tadashi Matsushita, and Masahiro Kajiki, and Goichi Honda, and Yoichi Sakata
May 2013, Thrombosis research,
Akira Shirahata, and Jun Mimuro, and Hoyu Takahashi, and Isao Kitajima, and Hajime Tsuji, and Yutaka Eguchi, and Tadashi Matsushita, and Masahiro Kajiki, and Goichi Honda, and Yoichi Sakata
May 2016, Anticancer research,
Akira Shirahata, and Jun Mimuro, and Hoyu Takahashi, and Isao Kitajima, and Hajime Tsuji, and Yutaka Eguchi, and Tadashi Matsushita, and Masahiro Kajiki, and Goichi Honda, and Yoichi Sakata
August 2015, The Journal of surgical research,
Akira Shirahata, and Jun Mimuro, and Hoyu Takahashi, and Isao Kitajima, and Hajime Tsuji, and Yutaka Eguchi, and Tadashi Matsushita, and Masahiro Kajiki, and Goichi Honda, and Yoichi Sakata
August 2015, International journal of clinical oncology,
Akira Shirahata, and Jun Mimuro, and Hoyu Takahashi, and Isao Kitajima, and Hajime Tsuji, and Yutaka Eguchi, and Tadashi Matsushita, and Masahiro Kajiki, and Goichi Honda, and Yoichi Sakata
May 2019, Anticancer research,
Akira Shirahata, and Jun Mimuro, and Hoyu Takahashi, and Isao Kitajima, and Hajime Tsuji, and Yutaka Eguchi, and Tadashi Matsushita, and Masahiro Kajiki, and Goichi Honda, and Yoichi Sakata
September 2013, Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis,
Akira Shirahata, and Jun Mimuro, and Hoyu Takahashi, and Isao Kitajima, and Hajime Tsuji, and Yutaka Eguchi, and Tadashi Matsushita, and Masahiro Kajiki, and Goichi Honda, and Yoichi Sakata
November 2018, Medicine,
Akira Shirahata, and Jun Mimuro, and Hoyu Takahashi, and Isao Kitajima, and Hajime Tsuji, and Yutaka Eguchi, and Tadashi Matsushita, and Masahiro Kajiki, and Goichi Honda, and Yoichi Sakata
October 2015, Critical care (London, England),
Akira Shirahata, and Jun Mimuro, and Hoyu Takahashi, and Isao Kitajima, and Hajime Tsuji, and Yutaka Eguchi, and Tadashi Matsushita, and Masahiro Kajiki, and Goichi Honda, and Yoichi Sakata
August 1993, Thrombosis research,
Akira Shirahata, and Jun Mimuro, and Hoyu Takahashi, and Isao Kitajima, and Hajime Tsuji, and Yutaka Eguchi, and Tadashi Matsushita, and Masahiro Kajiki, and Goichi Honda, and Yoichi Sakata
May 2017, Thrombosis and haemostasis,
Copied contents to your clipboard!