Treatment effects of recombinant human soluble thrombomodulin in patients with severe sepsis: A historical control study

Critical Care

Volumn 15, Issue 3, 2011, Pages

  Yamakawa, Kazuma ^a,b   Fujimi, Satoshi ^a   Mohri, Tomoyoshi ^a   Matsuda, Hiroki ^a   Nakamori, Yasushi ^a   Hirose, Tomoya ^b   Tasaki, Osamu ^b   Ogura, Hiroshi ^b   Kuwagata, Yasuyuki ^b   Hamasaki, Toshimitsu ^b   Shimazu, Takeshi ^b  

^a OSAKA GENERAL MEDICAL CENTER   (Japan)

^b OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; HYPERTENSIVE FACTOR; RECOMBINANT THROMBOMODULIN; STEROID; ANTICOAGULANT AGENT; RECOMBINANT PROTEIN; THROMBOMODULIN;

ANTIBIOTIC THERAPY; ARTICLE; ARTIFICIAL VENTILATION; CONTROL GROUP; CONTROLLED STUDY; DISEASE SEVERITY; DISSEMINATED INTRAVASCULAR CLOTTING; DRUG EFFICACY; DRUG INFUSION; FEMALE; GASTROINTESTINAL HEMORRHAGE; HUMAN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTIPLE ORGAN FAILURE; OUTCOME ASSESSMENT; PATHOPHYSIOLOGY; POST HOC ANALYSIS; PRIORITY JOURNAL; RESPIRATORY TRACT HEMORRHAGE; SCORING SYSTEM; SEPSIS; AGED; CASE CONTROL STUDY; MIDDLE AGED; TREATMENT OUTCOME;

AGED; ANTICOAGULANTS; CASE-CONTROL STUDIES; DISSEMINATED INTRAVASCULAR COAGULATION; FEMALE; HUMANS; MALE; MIDDLE AGED; RECOMBINANT PROTEINS; RESPIRATION, ARTIFICIAL; SEPSIS; THROMBOMODULIN; TREATMENT OUTCOME;

EID: 79955786719     PISSN: 13648535     EISSN: 1466609X     Source Type: Journal    
DOI: 10.1186/cc10228     Document Type: Article

References (26)

1. Zeerleder S, Hack CE, Wuillemin WA. Disseminated intravascular coagulation in sepsis. Chest 2005, 128:2864-2875. 10.1378/chest.128.4.2864, 16236964.
2. Esmon CT. The interactions between inflammation and coagulation. Br J Haematol 2005, 131:417-430. 10.1111/j.1365-2141.2005.05753.x, 16281932.
3. Ogura H, Gando S, Iba T, Eguchi Y, Ohtomo Y, Okamoto K, Koseki K, Mayumi T, Murata A, Ikeda T, Ishikura H, Ueyama M, Kushimoto S, Saitoh D, Endo S, Shimazaki S. SIRS-associated coagulopathy and organ dysfunction in critically ill patients with thrombocytopenia. Shock 2007, 28:411-417. 10.1097/shk.0b013e31804f7844, 17577138.
4. Bakhtiari K, Meijers JC, de Jonge E, Levi M. Prospective validation of the International Society of Thrombosis and Haemostasis scoring system for disseminated intravascular coagulation. Crit Care Med 2004, 32:2416-2421. 10.1097/01.CCM.0000147769.07699.E3, 15599145.
5. Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fisher CJ. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 2001, 344:699-709. 10.1056/NEJM200103083441001, 11236773.
6. Ely EW, Laterre PF, Angus DC, Helterbrand JD, Levy H, Dhainaut JF, Vincent JL, Macias WL, Bernard GR. Drotrecogin alfa (activated) administration across clinically important subgroups of patients with severe sepsis. Crit Care Med 2003, 31:12-19. 10.1097/00003246-200301000-00002, 12544987.
7. Dhainaut JF, Laterre PF, Janes JM, Bernard GR, Artigas A, Bakker J, Riess H, Basson BR, Charpentier J, Utterback BG, Vincent JL. Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: data from the PROWESS trial. Intensive Care Med 2003, 29:894-903.
8. Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med 2008, 36:296-327. 10.1097/01.CCM.0000298158.12101.41, 18158437.
9. Warren BL, Eid A, Singer P, Pillay SS, Carl P, Novak I, Chalupa P, Atherstone A, Penzes I, Kubler A, Knaub S, Keinecke HO, Heinrichs H, Schindel F, Juers M, Bone RC, Opal SM. Caring for the critically ill patient: High-dose antithrombin III in severe sepsis: a randomized controlled trial. JAMA 2001, 286:1869-1878. 10.1001/jama.286.15.1869, 11597289.
10. Van de Wouwer M, Collen D, Conway EM. Thrombomodulin-protein C-EPCR system: integrated to regulate coagulation and inflammation. Arterioscler Thromb Vasc Biol 2004, 24:1374-1383. 10.1161/01.ATV.0000134298.25489.92, 15178554.
11. Delvaeye M, Noris M, De Vriese A, Esmon CT, Esmon NL, Ferrell G, Del-Favero J, Plaisance S, Claes B, Lambrechts D, Zoja C, Remuzzi G, Conway EM. Thrombomodulin mutations in atypical hemolytic-uremic syndrome. N Engl J Med 2009, 361:345-357. 10.1056/NEJMoa0810739, 19625716.
12. Silasi-Mansat R, Zhu H, Popescu NI, Peer G, Sfyroera G, Magotti P, Ivanciu L, Lupu C, Mollnes TE, Taylor FB, Kinasewitz G, Lambris JD, Lupu F. Complement inhibition decreases the procoagulant response and confers organ protection in a baboon model of Escherichia coli sepsis. Blood 2010, 116:1002-1010. 10.1182/blood-2010-02-269746, 20466856.
13. Abeyama K, Stern DM, Ito Y, Kawahara K, Yoshimoto Y, Tanaka M, Uchimura T, Ida N, Yamazaki Y, Yamada S, Yamamoto Y, Yamamoto H, Iino S, Taniguchi N, Maruyama I. The N-terminal domain of thrombomodulin sequesters high-mobility group-B1 protein, a novel antiinflammatory mechanism. J Clin Invest 2005, 115:1267-1274. 1077171, 15841214.
14. Shi CS, Shi GY, Hsiao SM, Kao YC, Kuo KL, Ma CY, Kuo CH, Chang BI, Chang CF, Lin CH, Wong CH, Wu HL. Lectin-like domain of thrombomodulin binds to its specific ligand Lewis Y antigen and neutralizes lipopolysaccharide-induced inflammatory response. Blood 2008, 112:3661-3670. 10.1182/blood-2008-03-142760, 2572793, 18711002.
15. Saito H, Maruyama I, Shimazaki S, Yamamoto Y, Aikawa N, Ohno R, Hirayama A, Matsuda T, Asakura H, Nakashima M, Aoki N. 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, 5:31-41. 10.1111/j.1538-7836.2006.02267.x, 17059423.
16. Cheng B, Chow S. Validity of LOCF. Encyclopedia of Biopharmaceutical Statistics 2003, 1023-1029. London: Informa Healthcare, Chow S, 2.
17. Nagato M, Okamoto K, Abe Y, Higure A, Yamaguchi K. Recombinant human soluble thrombomodulin decreases the plasma high-mobility group box-1 protein levels, whereas improving the acute liver injury and survival rates in experimental endotoxemia. Crit Care Med 2009, 37:2181-2186. 10.1097/CCM.0b013e3181a55184, 19487933.
18. Iba T, Nakarai E, Takayama T, Nakajima K, Sasaoka T, Ohno Y. Combination effect of antithrombin and recombinant human soluble thrombomodulin in a lipopolysaccharide induced rat sepsis model. Crit Care 2009, 13:R203. 10.1186/cc8210, 2811901, 20003418.
19. Mohri M, Gonda Y, Oka M, Aoki Y, Gomi K, Kiyota T, Sugihara T, Yamamoto S, Ishida T, Maruyama I. 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, 8:274-283. 10.1097/00001721-199707000-00003, 9282791.
20. Levi M, van der Poll T. Recombinant human activated protein C: current insights into its mechanism of action. Crit Care 2007, 11(Suppl 5):S3. 10.1186/cc6154, 2230607, 18269690.
21. Xu J, Zhang X, Pelayo R, Monestier M, Ammollo CT, Semeraro F, Taylor FB, Esmon NL, Lupu F, Esmon CT. Extracellular histones are major mediators of death in sepsis. Nat Med 2009, 15:1318-1321. 10.1038/nm.2053, 2783754, 19855397.
22. Vincent JL, Angus DC, Artigas A, Kalil A, Basson BR, Jamal HH, Johnson G, Bernard GR. Effects of drotrecogin alfa (activated) on organ dysfunction in the PROWESS trial. Crit Care Med 2003, 31:834-840. 10.1097/01.CCM.0000051515.56179.E1, 12626993.
23. Laterre PF, Wittebole X, Dhainaut JF. Anticoagulant therapy in acute lung injury. Crit Care Med 2003, 31:S329-336. 10.1097/01.CCM.0000057912.71499.A5, 12682461.
24. Uchiba M, Okajima K, Murakami K, Johno M, Mohri M, Okabe H, Takatsuki K. rhs-TM prevents ET-induced increase in pulmonary vascular permeability through protein C activation. Am J Physiol 1997, 273:L889-L894.
25. Dhainaut JF, Yan SB, Margolis BD, Lorente JA, Russell JA, Freebairn RC, Spapen HD, Riess H, Basson B, Johnson G, Kinasewitz GT, . PROWESS Study Group Drotrecogin alfa (activated) (recombinant human activated protein C) reduces host coagulopathy response in patients with severe sepsis. Thromb Haemost 2003, 90:642-653. PROWESS Study Group.
26. Gentry CA, Gross KB, Sud B, Drevets DA. Adverse outcomes associated with the use of drotrecogin alfa (activated) in patients with severe sepsis and baseline bleeding precautions. Crit Care Med 2009, 37:19-25. 10.1097/CCM.0b013e318192843b, 19050637.