Postmarketing Surveillance of Recombinant Human Soluble Thrombomodulin (Thrombomodulin α) in Pediatric Patients With Disseminated Intravascular Coagulation

Akira Shirahata; Jun Mimuro; Hoyu Takahashi; Hajime Tsuji; Isao Kitajima; Tadashi Matsushita; Yutaka Eguchi; Naoya Kitamura; Goichi Honda; Yoichi Sakata

doi:10.1177/1076029614523490

Postmarketing Surveillance of Recombinant Human Soluble Thrombomodulin (Thrombomodulin α) in Pediatric Patients With Disseminated Intravascular Coagulation

Clin Appl Thromb Hemost. 2014 Jul;20(5):465-72. doi: 10.1177/1076029614523490. Epub 2014 Feb 20.

Authors

Affiliations

¹ University of Occupational and Environmental Health, Japan, Fukuoka, Japan a-shirahata@kitakyu-hp.or.jp.
² Division of Cell and Molecular Medicine, Center for Molecular Medicine, Jichi Medical University, School of Medicine, Tochigi, Japan The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin Injection, Tokyo, Japan.
³ The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin Injection, Tokyo, Japan Department of Internal Medicine, Niigata Prefectural Kamo Hospital, Niigata, Japan.
⁴ The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin Injection, Tokyo, Japan Department of Blood Transfusion, Kyoto Prefectural University of Medicine, Kyoto, Japan.
⁵ The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin Injection, Tokyo, Japan Department of Clinical Laboratory and Molecular Pathology, Graduate School of Medical and Pharmaceutical Science, University of Toyama, Toyama, Japan.
⁶ The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin Injection, Tokyo, Japan Department of Transfusion Medicine, Nagoya University Hospital, Aichi, Japan.
⁷ The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin Injection, Tokyo, Japan Critical and Intensive Care Medicine, Shiga University of Medical Science, Shiga, Japan.
⁸ ART Project, Pharmaceutical Sales Division, Asahi Kasei Pharma Corporation, Tokyo, Japan.

PMID: 24563247
DOI: 10.1177/1076029614523490

Abstract

Recombinant human soluble thrombomodulin (thrombomodulin α [TM-α]) has been marketed as a novel anticoagulant for disseminated intravascular coagulation (DIC) in Japan since 2008. Postmarketing surveillance (PMS) has been conducted since its approval. As effectiveness and safety were not previously determined in pediatric patients, this study evaluated PMS data and examined the usefulness of TM-α in treating pediatric DIC. After excluding newborn infants, data for 210 pediatric patients were analyzed and compared to 3786 adult patients. The day after the last TM-α administration, DIC had resolved in 58.5% of the patients. At 28 days after the last TM-α administration, the survival rate was 71.6%. Nineteen episodes of adverse drug reactions were observed in 11 patients but no significant differences were noted for effectiveness and safety. Although this study was limited by its retrospective design, including selection biases and no limitation on concomitant use of other anticoagulants, TM-α appears to be useful for the treatment of DIC in both pediatric and adult patients.

Keywords: anticoagulant; disseminated intravascular coagulation; pediatric patients; thrombomodulin.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Adult
Anticoagulants / administration & dosage*
Anticoagulants / adverse effects*
Child
Child, Preschool
Disseminated Intravascular Coagulation / drug therapy*
Female
Humans
Infant
Male
Product Surveillance, Postmarketing*
Recombinant Proteins / therapeutic use
Thrombomodulin / administration & dosage*

Substances

Anticoagulants
Recombinant Proteins
THBD protein, human
Thrombomodulin