Postmarketing surveillance of recombinant human soluble thrombomodulin (thrombomodulin α) in pediatric patients with disseminated intravascular coagulation

Clinical and Applied Thrombosis/Hemostasis

Volumn 20, Issue 5, 2014, Pages 465-472

  Shirahata, Akira ^a   Mimuro, Jun ^b,c   Takahashi, Hoyu ^c,d   Tsuji, Hajime ^c,e   Kitajima, Isao ^c,f   Matsushita, Tadashi ^c,g   Eguchi, Yutaka ^c,h   Kitamura, Naoya ⁱ   Honda, Goichi ⁱ   Sakata, Yoichi ^b,c  

^a UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

^b JICHI MEDICAL UNIVERSITY   (Japan)

^c Japanese Society on Thrombosis and Hemostasis Post Marketing Surveillance Committee for Recomodulin Injection   (Japan)

^d Niigata Prefectural Kamo Hospital   (Japan)

^e KYOTO PREFECTURAL UNIVERSITY OF MEDICINE   (Japan)

^f UNIVERSITY OF TOYAMA   (Japan)

^g NAGOYA UNIVERSITY HOSPITAL   (Japan)

^h SHIGA UNIVERSITY OF MEDICAL SCIENCE   (Japan)

ⁱ ASAHI KASEI PHARMA CORPORATION   (Japan)

Author keywords

anticoagulant; disseminated intravascular coagulation; pediatric patients; thrombomodulin

Indexed keywords

FRESH FROZEN PLASMA; NAFAMSTAT MESILATE; PROTEIN C; RECOMBINANT THROMBOMODULIN; THROMBOCYTE CONCENTRATE; ANTICOAGULANT AGENT; RECOMBINANT PROTEIN; THBD PROTEIN, HUMAN; THROMBOMODULIN;

ACUTE GRANULOCYTIC LEUKEMIA; ACUTE LYMPHOBLASTIC LEUKEMIA; ACUTE MONOCYTIC LEUKEMIA; ADOLESCENT; ADULT; ARTICLE; BLADDER BLEEDING; BLOOD CLOTTING PARAMETERS; BLOOD CLOTTING TEST; BLOOD TRANSFUSION; BRAIN INFARCTION; CATHETER SITE BLEEDING; CHILD; CHILDHOOD DISEASE; CLINICAL ARTICLE; CONTROLLED STUDY; DISEASE CLASSIFICATION; DISSEMINATED INTRAVASCULAR CLOTTING; DRUG EFFICACY; DRUG SAFETY; ENCEPHALITIS; EPISTAXIS; ERYTHROCYTE CONCENTRATE; FEMALE; FIBRINOGEN AND FIBRIN DEGRADATION PRODUCT; GASTROINTESTINAL HEMORRHAGE; HEMATOTHORAX; HEMATURIA; HISTIOCYTOSIS; HUMAN; INFANT; INJECTION SITE BLEEDING; INTESTINAL BLEEDING; JAPANESE MINISTRY OF HEALTH AND WELFARE CRITERIA; LIVER DYSFUNCTION; LUNG HEMORRHAGE; MALE; MELENA; MENINGITIS; ORAL BLEEDING; PARTIAL THROMBOPLASTIN TIME; PNEUMONIA; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROTHROMBIN TIME; PULMONARY ALVEOLAR BLEEDING; PUNCTURE SITE BLEEDING; RECTUM HEMORRHAGE; RESPIRATORY TRACT HEMORRHAGE; RETROSPECTIVE STUDY; SELECTION BIAS; SEPTIC SHOCK; SURVIVAL RATE; THROMBOCYTE COUNT; DISSEMINATED INTRAVASCULAR COAGULATION; PRESCHOOL CHILD;

ADOLESCENT; ADULT; ANTICOAGULANTS; CHILD; CHILD, PRESCHOOL; DISSEMINATED INTRAVASCULAR COAGULATION; FEMALE; HUMANS; INFANT; MALE; PRODUCT SURVEILLANCE, POSTMARKETING; RECOMBINANT PROTEINS; THROMBOMODULIN;

EID: 84901716171     PISSN: 10760296     EISSN: 19382723     Source Type: Journal    
DOI: 10.1177/1076029614523490     Document Type: Article

References (20)

1. Levi M, Ten Cate H. Disseminated intravascular coagulation. N Engl J Med. 1999 ; 341 (8). 586-592
2. Taylor FB, Toh CH, Hoots WK, Wada H, Levi M. Towards definition, clinical and laboratory criteria, and a scoring system for disseminated intravascular coagulation. Thromb Haemost. 2001 ; 86 (5). 1327-1330
3. Levi M, Toh CH, Thachil J, Watson HG. British committee for standards in haematology. Br J Haematol. 2009 ; 145 (1). 24-33
4. El-Nawawy A, Abbassy AA, El-Bordiny M, Essawi S. Evaluation of early detection and management of disseminated intravascular coagulation among Alexandria University pediatric intensive care patients. J Trop Pediat. 2004 ; 50 (6). 339-347
5. Ören H, Cingöz I, Duman M, Yilmaz S, Irken G. Disseminated intravascular coagulation in pediatric patients: clinical and laboratory features and prognostic factors influencing the survival. J Pediatr Hematol Oncol. 2005 ; 22 (8). 679-688
6. Montgomery RR, Scott JP Behrman RE, Kliegman RM, Jenson HB Nelson Textbook of Pediatrics. 16 th ed. Philadelphia: WB Saunders Company; 2000:1519-1520. Philadelphia: WB Saunders Company ; 2000: 1519-1520.
7. Saito H, Maruyama I, Shimazaki S, et al. Efficacy and safety of recombinant human soluble thrombomodulin (ART-123) in disseminated intravascular coagulation: results of a phase III, randomized, double-blind clinical trial. J Thromb Haemost. 2007 ; 5 (1). 31-41
8. Maruyama I. Recombinant thrombomodulin and activated protein C in the treatment of disseminated intravascular coagulation. Thromb Haemost. 1999 ; 82 (2). 718-721
9. Mohri M, Sugimoto E, Sata M, Asano T. The inhibitory effect of recombinant human soluble thrombomodulin on initiation and extension of coagulation: a comparison with other anticoagulants. Thromb Haemost. 1999 ; 82 (6). 1687-1693
10. White B, Schmidt M, Murphy C, et al. Activated protein C inhibits lipopolysaccharide-induced nuclear translocation of nuclear factor κB (NF-κB) and tumor necrosis factor α (TNF-α) production in the THP-1 monocytic cell line. Br J Haematol. 2000 ; 110 (1). 130-134
11. Bae JS, Rezaie AR. Thrombin inhibits nuclear factor κB and RhoA pathways in cytokine-stimulated vascular endothelial cells when EPCR is occupied by protein C. Thromb Haemost. 2009 ; 101 (3). 513-520
12. Abeyama K, Stern DM, Ito Y, et al. The N-terminal domain of thrombomodulin sequesters high-mobility group-B1 protein, a novel anti-inflammatory mechanism. J Clin Invest. 2005 ; 115 (5). 1267-1274
13. Shi CS, Shi GY, Hsiao SM, et al. Lectin-like domain of thrombomodulin binds to its specific ligand Lewis Y antigen and neutralizes lipopolysaccharide-induced inflammatory response. Blood. 2008 ; 112 (9). 3661-3670
14. Mimuro J, Takahashi H, Kitajima I, et al. Impact of recombinant soluble thrombomodulin (thrombomodulin alfa) on disseminated intravascular coagulation. Thromb Res. 2013 ; 131 (5). 436-443
15. Yagasaki H, Kato M, Shimozawa K, et al. Treatment responses for disseminated intravascular coagulation in 25 children treated with recombinant thrombomodulin: a single institution experience. Thromb Res. 2012 ; 130 (6). e289 - e293
16. Kobayashi N, Maekawa T, Takada M, Tanaka H, Gonmori H. Criteria for diagnosis of DIC based on the analysis of clinical and laboratory findings in 345 DIC patients collected by the research committee on DIC in Japan. Bibl Haematol. 1983 ; (49). 265-275
17. Tsuruta K, Yamada Y, Serada M, Tanigawara Y. Model-based analysis of covariate effects on population pharmacokinetics of thrombomodulin alfa in patients with disseminated intravascular coagulation and normal subjects. J Clin Pharmacol. 2011 ; 51 (9). 1276-1285
18. Mohri M. ART-123: recombinant human soluble thrombomodulin. Cardiovasc Drug Rev. 2000 ; 18 (4). 312-325
19. Nadal S, Goldstein B, William MD, et al. Drotrecogin alfa (activated) in children with severe sepsis: a multicentre phase III randomized controlled trial. Lancet. 2007 ; 369 (9564). 836-843
20. Nevo S, Enger C, Swan V, et al. Acute bleeding after allogeneic bone marrow transplantation: association with graft versus host disease and effect on survival. Transplantation. 1999 ; 67 (5). 681-689