Recombinant soluble human thrombomodulin (thrombomodulin alfa) in the treatment of neonatal disseminated intravascular coagulation View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2013-09-05

AUTHORS

Akira Shirahata, Jun Mimuro, Hoyu Takahashi, Isao Kitajima, Hajime Tsuji, Yutaka Eguchi, Tadashi Matsushita, Masahiro Kajiki, Goichi Honda, Yoichi Sakata

ABSTRACT

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. Conclusion: This surveillance provided real-world data on the safety and effectiveness of TM-alpha in the treatment of neonatal DIC in general practice settings. More... »

PAGES

303-311

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00431-013-2155-8

DOI

http://dx.doi.org/10.1007/s00431-013-2155-8

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1004450685

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/24005342


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