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

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.

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Abbreviations

ADRs:

Adverse drug reactions

AEs:

Adverse events

DIC:

Disseminated intravascular coagulation

FDP:

Fibrinogen/fibrin degradation products

JMHW:

Japanese Ministry of Health and Welfare

PMS:

Post-marketing surveillance

TM:

Thrombomodulin

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Acknowledgments

This study used the TM-α PMS database. We wish to thank all the participating physicians and registered patients who took part in this surveillance. We are also grateful to Katsuhito Nihashi for his support with statistical analyses. This surveillance was supported in part by the Japanese Society on Thrombosis and Hemostasis.

Conflict of interest

Masahiro Kajiki and Goichi Honda are employees of Asahi Kasei Pharma Corporation. The other authors have no competing financial interests to declare.

Author information

Correspondence to Akira Shirahata.

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Shirahata, A., Mimuro, J., Takahashi, H. et al. Recombinant soluble human thrombomodulin (thrombomodulin alfa) in the treatment of neonatal disseminated intravascular coagulation. Eur J Pediatr 173, 303–311 (2014). https://doi.org/10.1007/s00431-013-2155-8

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Keywords

  • Disseminated intravascular coagulation (DIC)
  • Thrombomodulin
  • Neonatal
  • Post-marketing surveillance