Recombinant Human Soluble Thrombomodulin in Sepsis-Induced Coagulopathy: An Updated Systematic Review and Meta-Analysis

Thrombosis and Haemostasis

Volumn 119, Issue 1, 2019, Pages 56-65

  Yamakawa, Kazuma ^a   Murao, Shuhei ^a   Aihara, Morio ^b  

^a OSAKA GENERAL MEDICAL CENTER   (Japan)

^b HIROSAKI UNIVERSITY   (Japan)

Author keywords

anticoagulants; coagulopathy; critically ill; disseminated intravascular coagulation; septic shock

Indexed keywords

HEPARIN; RECOMBINANT HUMAN SOLUBLE THROMBOMODULIN; THROMBOMODULIN; UNCLASSIFIED DRUG; ANTICOAGULANT AGENT; RECOMBINANT PROTEIN; THBD PROTEIN, HUMAN;

ALL CAUSE MORTALITY; BLEEDING; BLOOD CLOTTING DISORDER; FOLLOW UP; HUMAN; META ANALYSIS; MORTALITY RISK; OUTCOME ASSESSMENT; REVIEW; RISK REDUCTION; SEPSIS; SYSTEMATIC REVIEW; TREATMENT OUTCOME; BLOOD; COMPLICATION; CRITICAL ILLNESS; DISSEMINATED INTRAVASCULAR CLOTTING; MULTICENTER STUDY (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK;

ANTICOAGULANTS; BLOOD COAGULATION DISORDERS; CLINICAL TRIALS, PHASE III AS TOPIC; CRITICAL ILLNESS; DISSEMINATED INTRAVASCULAR COAGULATION; HUMANS; MULTICENTER STUDIES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECOMBINANT PROTEINS; RISK; SEPSIS; THROMBOMODULIN;

EID: 85059278459     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0038-1676345     Document Type: Review

References (37)

1. Ferrer R. Artigas A. Levy M. M., et al. Edusepsis Study Group. Improvement in process of care and outcome after a multicenter severe sepsis educational program in Spain. JAMA: 2008; 299 19 2294 2303
2. Levy M. M. Dellinger R. P. Townsend S. R., et al. The Surviving Sepsis Campaign: results of an international guideline-based performance improvement program targeting severe sepsis. Intensive Care Med: 2010; 36 02 222 231
3. Miller R. R. III. Dong L. Nelson N. C., et al. Intermountain Healthcare Intensive Medicine Clinical Program. Multicenter implementation of a severe sepsis and septic shock treatment bundle. Am J Respir Crit Care Med: 2013; 188 01 77 82
4. Rhodes A. Evans L. E. Alhazzani W., et al. Surviving Sepsis Campaign: international guidelines for management of sepsis and septic shock: 2016. Crit Care Med: 2017; 45 03 486 552
5. Ito T. Maruyama I. Thrombomodulin: protectorate God of the vasculature in thrombosis and inflammation. J Thromb Haemost: 2011; 9 01 168 173
6. Levi M. Van Der Poll T. Thrombomodulin in sepsis. Minerva Anestesiol: 2013; 79 03 294 298
7. Weiler H. Isermann B. H. Thrombomodulin. J Thromb Haemost: 2003; 1 07 1515 1524
8. Esmon C. T. The regulation of natural anticoagulant pathways. Science: 1987; 235 (4794): 1348 1352
9. Esmon C. T. The roles of protein C and thrombomodulin in the regulation of blood coagulation. J Biol Chem: 1989; 264 09 4743 4746
10. Okamoto T. Tanigami H. Suzuki K. Shimaoka M. Thrombomodulin: a bifunctional modulator of inflammation and coagulation in sepsis. Crit Care Res Pract: 2012; 2012 614545
11. Nakahara M. Ito T. Kawahara K., et al. Recombinant thrombomodulin protects mice against histone-induced lethal thromboembolism. PLoS One: 2013; 8 09 e75961
12. Ito T. Kawahara K. Nakamura T., et al. High-mobility group box 1 protein promotes development of microvascular thrombosis in rats. J Thromb Haemost: 2007; 5 01 109 116
13. Abeyama K. Stern D. M. Ito Y., et al. The N-terminal domain of thrombomodulin sequesters high-mobility group-B1 protein, a novel antiinflammatory mechanism. J Clin Invest: 2005; 115 05 1267 1274
14. Li Y. H. Kuo C. H. Shi G. Y. Wu H. L. The role of thrombomodulin lectin-like domain in inflammation. J Biomed Sci: 2012; 19 34
15. Mohri M. Gonda Y. Oka M., et al. The antithrombotic effects of recombinant human soluble thrombomodulin (rhsTM) on tissue factor-induced disseminated intravascular coagulation in crab-eating monkeys (Macaca fascicularis). Blood Coagul Fibrinolysis: 1997; 8 05 274 283
16. Tanaka K. Tawara S. Tsuruta K. Hoppensteadt D. Fareed J. Pharmacological differentiation of thrombomodulin alfa and activated protein C on coagulation and fibrinolysis in vitro. Clin Appl Thromb Hemost: 2018; 24 06 859 866
17. Yamakawa K. Aihara M. Ogura H. Yuhara H. Hamasaki T. Shimazu T. Recombinant human soluble thrombomodulin in severe sepsis: a systematic review and meta-analysis. J Thromb Haemost: 2015; 13 04 508 519
18. Asahi Kasei Pharma America Corporation. Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy. Available at: https://clinicaltrials.gov/ct2/show/NCT01598831?cond=ART-123&rank=5. Accessed August 2, 2018
19. Asahi Kasei Pharma Corporation. Preliminary results of overseas Phase III clinical study for ART-123; 2018. Available at: https://www.asahi-kasei.co.jp/asahi/en/news/2018/e180802.html. Accessed August 2, 2018
20. Moher D. Liberati A. Tetzlaff J. Altman D. G.; PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA statement. J Clin Epidemiol: 2009; 62 10 1006 1012
21. Liberati A. Altman D. G. Tetzlaff J., et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol: 2009; 62 10 e1 e34
22. Ouzzani M. Hammady H. Fedorowicz Z. Elmagarmid A. Rayyan - a web and mobile app for systematic reviews. Syst Rev: 2016; 5 01 210
23. Aihara M. GRADE system for clinical practice guideline. 2nd ed. Hirosaki: Toppan Media; 2015
24. Schünemann H. Brozek J. Guyatt G. Oxman A. GRADE Handbook for Grading the Quality of Evidence and the Strength of Recommendations Using the GRADE Approach. Updated Oc. Available at: www.guidelinedevelopment.org/handbook. Accessed November 18, 2018
25. Hayakawa M. Saito S. Uchino S., et al. Characteristics, treatments, and outcomes of severe sepsis of 3195 ICU-treated adult patients throughout Japan during 2011-2013. J Intensive Care: 2016; 4 44
26. Higgins J. P. Thompson S. G. Quantifying heterogeneity in a meta-analysis. Stat Med: 2002; 21 11 1539 1558
27. Wetterslev J. Thorlund K. Brok J. Gluud C. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J Clin Epidemiol: 2008; 61 01 64 75
28. Brok J. Thorlund K. Gluud C. Wetterslev J. Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses. J Clin Epidemiol: 2008; 61 08 763 769
29. Aikawa N. Shimazaki S. Yamamoto Y., et al. Thrombomodulin alfa in the treatment of infectious patients complicated by disseminated intravascular coagulation: subanalysis from the phase 3 trial. Shock: 2011; 35 04 349 354
30. Ushizawa H. Isotani E. Takahashi H. Sera T. Otomo Y. Randomized controlled trial of novel recombinant human soluble thrombomodulin (RTM) for sepsis with disseminated intravascular coagulation patients in Japan. Intensive Care Med: 2012; 38 01 S293 S294
31. Vincent J. L. Ramesh M. K. Ernest D., et al. 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. Crit Care Med: 2013; 41 09 2069 2079
32. Hagiwara A. Tanaka N. Uemura T. Matsuda W. Kimura A. Can recombinant human thrombomodulin increase survival among patients with severe septic-induced disseminated intravascular coagulation: a single-centre, open-label, randomised controlled trial. BMJ Open: 2016; 6 12 e012850
33. Takahashi H. Isotani E. Ushizawa H., et al. Effect of recombinant thrombomodulin for sepsis-induced disseminated intravascular coagulation. ICU&CCU: 2011; 35 581 584
34. Asahi Kasei Pharma America Corporation. The Safety And Efficacy of ART-123 in Subjects With Sepsis and Coagulopathy (Scarlet2). Available at: https://clinicaltrials.gov/ct2/show/NCT03517501?cond=ART-123&rank=3. Accessed August 2, 2018
35. Umemura Y. Yamakawa K. Optimal patient selection for anticoagulant therapy in sepsis: an evidence-based proposal from Japan. J Thromb Haemost: 2018; 16 03 462 464
36. Umemura Y. Yamakawa K. Ogura H. Yuhara H. Fujimi S. Efficacy and safety of anticoagulant therapy in three specific populations with sepsis: a meta-analysis of randomized controlled trials. J Thromb Haemost: 2016; 14 03 518 530
37. Zhang C. Wang H. Yang H. Tong Z. Recombinant human soluble thrombomodulin and short-term mortality of infection patients with DIC: a meta-analysis. Am J Emerg Med: 2016; 34 09 1876 1882