Impact of recombinant soluble thrombomodulin (thrombomodulin alfa) on disseminated intravascular coagulation

Thrombosis Research

Volumn 131, Issue 5, 2013, Pages 436-443

  Mimuro, Jun ^a,b   Takahashi, Hoyu ^a,c   Kitajima, Isao ^a,d   Tsuji, Hajime ^a,e   Eguchi, Yutaka ^a,f   Matsushita, Tadashi ^a,g   Kuroda, Tatsuhiko ^h   Sakata, Yoichi ^a,b  

^a Japan Soc on Thromb and Hemostasis Post Mktg Surveillance Committee for Thrombomodulin Alfa   (Japan)

^b JICHI MEDICAL UNIVERSITY   (Japan)

^c Niigata Prefectural Kamo Hospital   (Japan)

^d UNIVERSITY OF TOYAMA   (Japan)

^e KYOTO PREFECTURAL UNIVERSITY OF MEDICINE   (Japan)

^f SHIGA UNIVERSITY OF MEDICAL SCIENCE   (Japan)

^g NAGOYA UNIVERSITY HOSPITAL   (Japan)

^h ASAHI KASEI PHARMA CORPORATION   (Japan)

Author keywords

disseminated intravascular coagulation; post marketing surveillance; recombinant soluble thrombomodulin

Indexed keywords

RECOMBINANT THROMBOMODULIN;

ADOLESCENT; ADULT; AGE; AGED; ANTICOAGULANT THERAPY; ARTICLE; BRAIN HEMORRHAGE; CHILD; CONTROLLED STUDY; DISEASE SEVERITY; DISSEMINATED INTRAVASCULAR CLOTTING; DRUG EFFICACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FEMALE; GASTROINTESTINAL HEMORRHAGE; HEMATOLOGIC MALIGNANCY; HUMAN; INFANT; INFECTION; MAJOR CLINICAL STUDY; MALE; MORBIDITY; PHASE 3 CLINICAL TRIAL (TOPIC); PRESCHOOL CHILD; PRIORITY JOURNAL; RESPIRATORY TRACT HEMORRHAGE; RISK FACTOR; SCHOOL CHILD; SCORING SYSTEM; SURVIVAL RATE;

CLINICAL TRIALS, PHASE III AS TOPIC; DISSEMINATED INTRAVASCULAR COAGULATION; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECOMBINANT PROTEINS; RISK FACTORS; SURVIVAL RATE; THROMBOMODULIN;

EID: 84877786299     PISSN: 00493848     EISSN: 18792472     Source Type: Journal    
DOI: 10.1016/j.thromres.2013.03.008     Document Type: Article

References (28)

1. M. Levi, and H. Ten Cate Disseminated intravascular coagulation N Engl J Med 341 1999 586 592
2. F.B. Taylor Jr., C.H. Toh, W.K. Hoots, H. Wada, and M. Levi Towards definition, clinical and laboratory criteria, and a scoring system for disseminated intravascular coagulation Thromb Haemost 86 2001 1327 1330
3. C.H. Toh, and M. Dennis Disseminated intravascular coagulation: old disease, new hope BMJ 327 2003 974 977
4. M. Levi, C.H. Toh, J. Thachil, and H.G. Watson Guidelines for the diagnosis and management of disseminated intravascular coagulation. British Committee for Standards in Haematology Br J Haematol 145 2009 24 33
5. T. Ono, J. Mimuro, S. Madoiwa, K. Soejima, Y. Kashiwakura, and A. Ishiwata Severe secondary deficiency of von Willebrand factor-cleaving protease (ADAMTS13) in patients with sepsis-induced disseminated intravascular coagulation: its correlation with development of renal failure Blood 107 2006 528 534
6. S. Madoiwa, S. Nunomiya, T. Ono, Y. Shintani, T. Ohmori, and J. Mimuro Plasminogen activator inhibitor 1 promotes a poor prognosis in sepsis-induced disseminated intravascular coagulation Int J Hematol 84 2006 398 405
7. S. Madoiwa, H. Tanaka, Y. Nagahama, M. Dokai, Y. Kashiwakura, and A. Ishiwata Degradation of cross-linked fibrin by leukocyte elastase as alternative pathway for plasmin-mediated fibrinolysis in sepsis-induced disseminated intravascular coagulation Thromb Res 127 2011 349 355
8. J. Kienast, M. Juers, C.J. Wiedermann, J.N. Hoffmann, H. Ostermann, and R. Strauss Treatment effects of high-dose antithrombin without concomitant heparin in patients with severe sepsis with or without disseminated intravascular coagulation J Thromb Haemost 4 2006 90 97
9. H. Wada, H. Asakura, K. Okamoto, T. Iba, T. Uchiyama, and K. Kawasugi Expert consensus for the treatment of disseminated intravascular coagulation in Japan Thromb Res 125 2010 6 11
10. J.F. Dhainaut, S.B. Yan, D.E. Joyce, V. Pettila, B. Basson, and J.T. Brandt Treatment effects of drotrecogin alfa (activated) in patients with severe sepsis with or without overt disseminated intravascular coagulation J Thromb Haemost 2 2004 1924 1933
11. C. Alaniz An update on activated protein C (xigris) in the management of sepsis P T 35 2010 504 529
12. A. Mullard Drug withdrawal sends critical care specialists back to basics Lancet 378 2011 1769
13. M. Mohri, E. Sugimoto, M. Sata, and T. Asano The inhibitory effect of recombinant human soluble thrombomodulin on initiation and extension of coagulation-a comparison with other anticoagulants Thromb Haemost 82 1999 1687 1693
14. I. Maruyama Recombinant thrombomodulin and activated protein C in the treatment of disseminated intravascular coagulation Thromb Haemost 82 1999 718 721
15. H. Saito, I. Maruyama, S. Shimazaki, Y. Yamamoto, N. Aikawa, and R. Ohno 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 5 2007 31 41
16. S. Niimi, T. Oshizawa, M. Naotsuka, S. Ohba, A. Yokozawa, and T. Murata Establishment of a standard assay method for human thrombomodulin and determination of the activity of the Japanese reference standard Biologicals 30 2002 69 76
17. K. Tsuruta, Y. Yamada, M. Serada, and Y. Tanigawara Model-based analysis of covariate effects on population pharmacokinetics of thrombomodulin alfa in patients with disseminated intravascular coagulation and normal subjects J Clin Pharmacol 51 2011 1276 1285
18. N. Kobayashi, T. Maekawa, M. Takada, H. Tanaka, and H. Gonmori 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 49 1983 265 275
19. S. Gando, T. Iba, Y. Eguchi, Y. Ohtomo, K. Okamoto, and K. Koseki A multicenter, prospective validation of disseminated intravascular coagulation diagnostic criteria for critically ill patients: comparing current criteria Crit Care Med 34 2006 625 631
20. R.C. Bone, R.A. Balk, F.B. Cerra, R.P. Dellinger, A.M. Fein, and W.A. Knaus Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. 1992 Chest 136 2009 e28
21. ICH Steering Committee ICH Harmonised Tripartite Guideline. Clinical safety data management: definitions and standards for expedited reporting. Pharmaceuticals and Medical Devices Agency website [Internet. Accessed April 8, 2011.] Available from: http://www.pmda.go.jp/ich/e/e2a-95-3-20e.pdf
22. Z.A. Marcum, J.P. Vande Griend, and S.A. Linnebur FDA Drug Safety Communications: A narrative review and clinical considerations for older adults Am J Geriatr Pharmacother 10 2012 264 271
23. C. Stöllberger, and J. Finsterer Letter by Stollberger and Finsterer regarding article, "intracranial hemorrhage in patients with atrial fibrillation during anticoagulation with Warfarin or Dabigatran: The randomized evaluation of long-term anticoagulant therapy (RE-LY) trial" Stroke 43 2012 e93
24. K. Yamakawa, S. Fujimi, T. Mohri, H. Matsuda, Y. Nakamori, and T. Hirose Treatment effects of recombinant human soluble thrombomodulin in patients with severe sepsis: a historical control study Crit Care 15 2011 R123
25. Y. Ogawa, K. Yamakawa, H. Ogura, T. Kiguchi, T. Mohri, and Y. Nakamori Recombinant human soluble thrombomodulin improves mortality and respiratory dysfunction in patients with severe sepsis J Trauma Acute Care Surg 72 2012 1150 1157
26. I. Kaul, K. Tsuruta, K. Gorelick, Y. Osawa, D. Hoppensteadt, and J. Fareed A randomized, double-blind, placebo-controlled, phase-2B study to evaluate the safety and efficacy of recombinant human soluble thrombomodulin, ART-123, in patients with sepsis and suspected disseminated intravascular coagulation Blood 120 2012 [(ASH Annual Meeting Abstracts), Abstract 24]
27. K. Yamakawa, H. Ogura, S. Fujimi, M. Morikawa, Y. Ogawa, and T. Mohri Recombinant human soluble thrombomodulin in sepsis-induced disseminated intravascular coagulation: a multicenter propensity score analysis Intensive Care Med Jan 30 2013 [Epub ahead of print]
28. T. Ikezoe, A. Takeuchi, M. Isaka, Y. Arakawa, N. Iwabu, and T. Kin Recombinant human soluble thrombomodulin safely and effectively rescues acute promyelocytic leukemia patients from disseminated intravascular coagulation Leuk Res 36 2012 1398 1402