A randomized clinical trial of unfractioned heparin for treatment of sepsis (the HETRASE study): Design and rationale [NCT00100308]

Trials

Volumn 7, Issue , 2006, Pages

  Jaimes, Fabián ^a,b   De La Rosa, Gisela ^a   Arango, Clara ^a   Fortich, Fernando ^a   Morales, Carlos ^a   Aguirre, Daniel ^a   Patiño, Pablo ^a  

^a UNIVERSIDAD DE ANTIOQUIA   (Colombia)

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

D DIMER; HEPARIN; PLACEBO;

ADULT; APACHE; ARTICLE; CLINICAL TRIAL; COLOMBIA; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG MECHANISM; DRUG USE; EMERGENCY WARD; FEMALE; HOSPITALIZATION; HUMAN; LENGTH OF STAY; LOW DRUG DOSE; MALE; MORTALITY; MULTIPLE ORGAN FAILURE; OUTCOME ASSESSMENT; PATIENT CARE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SEPSIS; UNIVERSITY HOSPITAL;

EID: 33745316366     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-7-19     Document Type: Article

References (38)

1. Slade E, Tamber PS, Vincent JL: The Surviving Sepsis Campaign: raising awareness to reduce mortality. Crit Care 2003, 7:1-2.
2. Jaimes F, Valencia M, L. V: Significado Clínico cle los Hemocultivos. Una Cohorte Retrospectiva en el Hospital San Vicente de Paul. Infectio 1998, 2:69-76.
3. Jaimes F, Garcés J, Cuervo J, Ramírez JH, Ramírez F, Estrada JC, et al.: Factores pronósticos en el síndrome de respuesta inflamatoria sistémica (SRIS). Desarrollo de un índice de severidad. Acta Medica Colombiana 2001, 26:149-157.
4. Jaimes F, Arango C, Ruiz G, Cuervo J, Botero J, Velez G, Upegui N, Machado F: Predicting bacteremia at the bedside. Clin Infect Dis 2004, 38:357-362.
5. Martin GS, Mannino DM, Eaton S, M M: The epidemiology of sepsis in the United Sates from 1979 through 2000. N Engl J Med 2003, 348:1546-1554.
6. Bernard GR, Vincent J-L, Laterre P-F, LaRosa SP, Dhainaut J-F, Lopez-Rodriguez A, al.: Efficacy and safety of recombinant human activated Protein C for severe sepsis. N Engl J Med 2001, 344:699-709.
7. Annane D, Sebille V, Charpentier C, Bollaert P-E, Francois B, Korach J-M, al.: Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA 2002, 288:862-871.
8. Wenzel RP: Perspective: treating sepsis. N Engl J Med 2002 347:966-967.
9. Angus DC, RS W: Epidemiology of sepsis: an update. Crit Care Med 2001, 29:S109-S116.
10. Hotchkiss RS, IE K: The pathophysiology and treatment of sepsis. N Engl J Med 2003, 348:138-150.
11. Opal S, CT E: Bench-to-bedside review: Functional relationships between coagulation and the innate immune response and their respective roles in the pathogenesis of sepsis. Critical Care 2003, 7:23-38.
12. Levi M, H TC: Current Concepts. Disseminated intravascular coagulation. N Engl J Med 1999, 341:586-592.
13. Levi M, De Jonge E, Van Der Poll T, H TC: Novel approaches to the management of disseminated intravascular coagulation. Crit Care Med 2000, 28:S20-S24.
14. Mavrommatis AC, Theodoridis T, Orfanidou A, Roussos C, Christopoulou-Kokkinou V, S Z: Coagulation system and platelets are fully activated in uncomplicated sepsis. Crit Care Med 2000, 28:451-457.
15. Opal S, Garber GE, LaRosa SP, Maki DG, Freebairn RC, Kinasewitz GT, al.: Systemic host responses in severe sepsis analyzed by causative microorganism and treatment effects of Drotrecogin Alfa (activated). Clin Infect Dis 2003, 37:50-58.
16. Opal S, Kessler CM, Roemisch J, Knaub S: Antithrombin, heparin, and heparan sulfate. Crit Care Med 2002, 30 (Suppl):S325-S331.
17. Amaral A, Opal SM, Vincent JL: Coagulation in sepsis. Intensive Care Med 2004, 30:1032-1040.
18. Hirsh J, Warkentin TE, Shaughnessy SG, Anand SS, Halperin JL, Raschke R, al: Heparin and Low-Molecular-Weight Heparin. Mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy, and safety. Chest 2001, 119:64S-94S.
19. Tanaka T, Tsujinaka T, Kambayashi J, Higashiyama M, Yokota M, Sakon M, Mori T: The effect of heparin on multiple organ failure and disseminated intravascular coagulation in a sepsis model. Thromb Res 1990, 60:321-330.
20. Meyer J, Cox CS, Herndon DN, Nakazawa H, Lentz CW, Traber LD, al: Heparin in experimental hyperdinamic sepsis. Crit Care Med 1993, 21:84-89.
21. Boldt J, Papsdorf M, Piper SK, Rothe A, Hempelmann G: Continuous heparinization and circulating adhesion molecules in the critically ill. Shock 1999, 11:13-18.
22. Pernerstorfer T, Hollenstein U, Hansen J-B, Knechtelsdorfer M, Stohlawetz P, Graninger W: Heparin blunts endotoxin-induced coagulation activation. Circulation 1999, 100:2485-2490.
23. Derhaschnig U, Pernerstorfer T, Knechtelsdorfer M, Hollenstein U, Panzer S, Jilma B: Evaluation of anti-inflammatory and antiadhesive effects of heparins in human endotoxemia. Crit Care Med 2003, 31:1108-1112.
24. Warren BL, Eid A, Singer P, Pillay SS, Carl P, I N, al.: High-dose anti-thrombin III in severe sepsis. A randomized controlled trial. JAMA 2001, 2001:1869-1878.
25. Abraham E, Reinhart K, Opal S, Demeyer I, Doig C, López Rodríguez A, al.: Efficacy and Safety of Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) in Severe Sepsis. A Randomized Controlled Trial. JAMA 2003, 290:238-247.
26. Angus DC, MA C: Unraveling severe sepsis. Why did OPTI-MIST fail and what's next? JAMA 2003, 290:256-258.
27. Ten Cate H: Pathophysiology of disseminated intravascular coagulation in sepsis. Crit Care Med 2000, 28:S9-S11.
28. Cook R, Cook DJ, Tilley J, Lee K, Marshall J: Multiple organ dysfunction: Baseline and serial components scores. Crit Care Med 2001, 29:2046-2050.
29. Jaimes F, Garces J, Cuervo J, Ramirez F, Ramirez J, Vargas A, Quintero C, Ochoa J, Tandioy F, Zapata L, Estrada J, Yepes M, Leal H: The systemic inflammatory response syndrome (SIRS) to identify infected patients in the emergency room. Intensive Care Med 2003, 29:1368-1371.
30. Garner JS, Jarvis WR, Emori TG, Horan TC, Hughes JM: CDC definitions for nosocomial infections. Am J Infect Control 1989, 16:128-140.
31. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. Journal of the American statistical association 1958, 53:457-481.
32. Diggle PJ, Liang K-Y, SL Z. Analysis of longitudinal data. Oxford, Oxford university press; 1994.
33. O'Brien PC, Fleming TR: A multiple testing procedure for clinical trials. Biometrics 1979, 35:549-556.
34. Fleming TR, Harrington DP, O'Brien PC: Designs for group sequential tests. Control Clin Trials 1984, 5:348-361.
35. Laird NM, Ware JH: Random-effects models for longitudinal data. Biometrics 1982, 38:963-974.
36. Cohen J, Guyatt G, Bernard GR, Calandra T, Cook D, Elbourne D, al: New strategies for clinical trials in patients with sepsis and septic shock. Crit Care Med 2001, 29:880-886.
37. Schiffer ER, Reber G, Moerloose P, Morel DR: Evaluation of unfractioned heparin and recombinant hirudin on survival in a sustained ovine endotoxin shock model. Crit Care Med 2002, 30:2689-2699.
38. Haneberg B, Gutteberg TJ, Moe PJ, Osterud B, Bjorvatn B, Lehmann EH: Heparin for infants and children with meningococcal septicemia. NIPH Ann 1983, 6:43-47.