Design and preliminary results of a pilot randomized controlled trial on a 1:1:1 transfusion strategy: The trauma formula-driven versus laboratory-guided study

Journal of Trauma - Injury, Infection and Critical Care

Volumn 71, Issue 5 SUPPL.1, 2011, Pages

  Nascimento, Bartolomeu ^a   Rizoli, Sandro ^a   Rubenfeld, Gordon ^a   Lin, Yulia ^a   Callum, Jeannie ^a   Tien, Homer C ^a  

^a SUNNYBROOK RESEARCH INSTITUTE   (Canada)

Author keywords

Clinical trial; Design; Massive transfusion; Trauma

Indexed keywords

FRESH FROZEN PLASMA;

ADULT; ARTICLE; BLEEDING; BLOOD CLOTTING TEST; CANADA; CLINICAL ARTICLE; CONTROLLED STUDY; ERYTHROCYTE TRANSFUSION; FEASIBILITY STUDY; FEMALE; HUMAN; INJURY SCALE; LABORATORY; MALE; PILOT STUDY; PLASMA TRANSFUSION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SHELF LIFE; STUDY DESIGN; THAWING; THROMBOCYTE TRANSFUSION; TURNAROUND TIME;

ADULT; BLOOD TRANSFUSION; CANADA; FEASIBILITY STUDIES; FEMALE; FOLLOW-UP STUDIES; HEMORRHAGE; HUMANS; MALE; MIDDLE AGED; PILOT PROJECTS; RESUSCITATION; RETROSPECTIVE STUDIES; SURVIVAL RATE; TRAUMA CENTERS; TREATMENT OUTCOME; WOUNDS AND INJURIES;

EID: 81455159199     PISSN: 00225282     EISSN: 15298809     Source Type: Journal    
DOI: 10.1097/TA.0b013e318232e591     Document Type: Article

References (52)

1. Borgman MA, Spinella PC, Perkins JG, et al. The ratio of blood products transfused affects mortality in patients receiving massive transfusions at a combat support hospital. J Trauma. 2007;63:805-813. (Pubitemid 350287298)
2. Spinella PC, Perkins JG, Grathwohl KW, et al. Effect of plasma and red blood cell transfusions on survival in patients with combat related traumatic injuries. J Trauma. 2008;64:S69-S77.
3. Cotton BA, Gunter OL, Isbell J, et al. Damage control hematology: the impact of a trauma exsanguination protocol on survival and blood product utilization. J Trauma. 2008;64:1177-1182. (Pubitemid 351671208)
4. Duchesne JC, Hunt JP, Wahl G, et al. Review of current blood transfusions strategies in a mature level I trauma center: were we wrong for the last 60 years? J Trauma. 2008 65 272-276.
5. Gunter OL Jr, Au BK, Isbell JM, Mowery NT, Young PP, Cotton BA. Optimizing outcomes in damage control resuscitation: identifying blood product ratios associated with improved survival. J Trauma. 2008;65: 527-534.
6. Maegele M, Lefering R, Paffrath T, Tjardes T, Simanski C, Bouillon B. Red-blood-cell to plasma ratios transfused during massive transfusion are associated with mortality in severe multiple injury: a retrospective analysis from the Trauma Registry of the Deutsche Gesellschaft fur Unfallchirurgie. Vox Sang. 2008;95:112-119. (Pubitemid 351951900)
7. Teixeira PG, Inaba K, Shulman I, et al. Impact of plasma transfusion in massively transfused trauma patients. J Trauma. 2009;66:693-697.
8. Zink KA, Sambasivan CN, Holcomb JB, Chisholm G, Schreiber MA. A high ratio of plasma and platelets to packed red blood cells in the first 6 hours of massive transfusion improves outcomes in a large multicenter study. Am J Surg. 2009;197:565-570.
9. Holcomb JB, Jenkins D, Rhee P, et al. Damage control resuscitation: directly addressing the early coagulopathy of trauma. J Trauma. 2007; 62:307-310.
10. Hess JR, Holcomb JB, Hoyt DB. Damage control resuscitation: the need for specific blood products to treat the coagulopathy of trauma. Transfusion. 2006;46:685-686.
11. Snyder CW, Weinberg JA, McGwin G Jr, et al. The relationship of blood product ratio to mortality: survival benefit or survival bias? J Trauma. 2009;66:358-362.
12. Nascimento B, Callum J, Rubenfeld G, Neto JB, Lin Y, Rizoli S. Clinical review: fresh frozen plasma in massive bleedings-more questions than answers. Crit Care. 2010;14:202.
13. Callum JL, Nascimento B, Tien H, Rizoli S. Editorial: "formula-driven" versus "lab-driven" massive transfusion protocols: at a state of clinical equipoise. Transfus Med Rev. 2009;23:247-254.
14. Stansbury LG, Dutton RP, Stein DM, Bochicchio GV, Scalea TM, Hess JR. Controversy in trauma resuscitation: do ratios of plasma to red blood cells matter? Transfus Med Rev. 2009;23:255-265.
15. Guyatt G, Gutterman D, Baumann MH, et al. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an American college of chest physicians task force. Chest. 2006;129:174-181. (Pubitemid 43265259)
16. Guyatt GH, Naylor D, Richardson WS, et al. What is the best evidence for making clinical decisions? JAMA. 2000;284:3127-3128. (Pubitemid 32039071)
17. Guyatt GH, Oxman AD, Vist GE, et al; GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336:924-926. (Pubitemid 351632017)
18. Dutton R, Hauser C, Boffard K, et al; CONTROL Steering Committee. Scientific and logistical challenges in designing the CONTROL trial: recombinant factor VIIa in severe trauma patients with refractory bleeding. Clin Trials. 2009;6:467-479.
19. Holcomb JB, Weiskopf R, Champion H, et al. Challenges to effective research in acute trauma resuscitation: consent and endpoints. Shock. 2011;35:107-113.
20. Moore FA, Nelson T, McKinley BA, et al; StO2 Study Group. Massive transfusion in trauma patients: tissue hemoglobin oxygen saturation predicts poor outcome. J Trauma. 2008;64:1010-1023. (Pubitemid 351521893)
21. Kashuk JL, Moore EE, Johnson JL, et al. Postinjury life threatening coagulopathy: is 1:1 fresh frozen plasma:packed red blood cells the answer? J Trauma. 2008;65:261-270.
22. Rizoli SB, Nascimento B Jr, Osman F, et al. Recombinant activated coagulation factor VII and bleeding trauma patients. J Trauma. 2006; 61:1419-1425. (Pubitemid 44973312)
23. Nunez TC, Voskresensky IV, Dossett LA, Shinall R, Dutton WD, Cotton BA. Early prediction of massive transfusion in trauma: simple as ABC (assessment of blood consumption)? J Trauma. 2009;66:346-352.
24. Hoyt DB, Bulger EM, Knudson MM, et al. Death in the operating room: an analysis of a multi-center experience. J Trauma. 1994;37:426-432. (Pubitemid 24288576)
25. Sauaia A, Moore FA, Moore EE, et al. Epidemiology of trauma deaths: a reassessment. J Trauma. 1995;38:185-193.
26. Acosta JA, Yang JC, Winchell RJ, et al. Lethal injuries and time to death in a level I trauma center. J Am Coll Surg. 1998;186:528-533. (Pubitemid 28222075)
27. Chandler WL, Ferrell C, Trimble S, Moody S. Development of a rapid emergency hemorrhage panel. Transfusion. 2010;50:2547-2552.
28. O'Shaughnessy DF, Atterbury C, Bolton MP, et al; British Committee for Standards in Haematology, Blood Transfusion Task Force. Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant. Br J Haematol. 2004;126:11-28. (Pubitemid 38859478)
29. Holcomb JB, Wade CE, Michalek JE, et al. Increased plasma and platelet to red blood cell ratios improves outcome in 466 massively transfused civiilan trauma patients. Ann Surg. 2008;248:447-458.
30. Malone DL, Hess JR, Fingerhut A. Massive transfusion practices around the globe and a suggestion for a common massive transfusion protocol. J Trauma. 2006;60:S91-S96.
31. Cotton BA, Dossett LA, Au BK, Nunez TC, Robertson AM, Young PP. Room for (performance) improvement: provider-related factors associated with poor outcomes in massive transfusion. J Trauma. 2009;67: 1004-1012.
32. Nunez TC, Young PP, Holcomb JB, Cotton BA. Creation, implementation, and maturation of a massive transfusion protocol for the exsanguinating trauma patient. J Trauma. 2010;68:1498-1505.
33. McLaughlin DF, Niles SE, Salinas J, et al. A predictive model for massive transfusion in combat casualty patients. J Trauma. 2008;64: S57-S63.
34. Yucel N, Lefering R, Maegele M, et al; Polytrauma Study Group of the German Trauma Society. Trauma Associated Severe Hemorrhage (TASH)-Score: probability of mass transfusion as surrogate for life threatening hemorrhage after multiple trauma. J Trauma. 2006;60: 1228-1236.
35. Cotton BA, Dossett LA, Haut ER, et al. Multicenter validation of a simplified score to predict massive transfusion in trauma. J Trauma. 2010;69(suppl 1):S33-S39.
36. Dutton RP, Stansbury LG, Hemlock B, Hess JR, Scalea TM. Impediments to obtaining informed consent for clinical research in trauma patients. J Trauma. 2008;64:1106-1112. (Pubitemid 351521908)
37. Burns KE, Zubrinich C, Marshall J, Cook D. The 'Consent to Research' paradigm in critical care: challenges and potential solutions. Intensive Care Med. 2009;35:1655-1658.
38. Annane D, Outin H, Fisch C, Bellissant E. The effect of waiving consent on enrollment in a sepsis trial. Intensive Care Med. 2004;30:321-324. (Pubitemid 38253426)
39. Cook D, Burns K, Finfer S, et al. Clinical research ethics for critically ill patients: a pandemic proposal. Crit Care Med. 2010;38:e138-e142.
40. Largent EA, Wendler D, Emanuel E, Miller FG. Is emergency research without initial consent justified?: the consent substitute model. Arch Intern Med. 2010;170:668-674.
41. Tri-Council Policy Working Party on Ethics: Draft 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Available at: http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS- 2-FINAL-Web.pdf. Accessed September 22, 2011.
42. Jansen TC, Bakker J, Kompanje EJ. Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results. Intensive Care Med. 2010;36:1962-1965.
43. Canadian Standards Association. Canadian Standards Association standard CAN/CSA/Z902: Blood and Blood Components. Mississauga, Ontario: Canadian Standards Association; 2004.
44. Pocock SJ, Abdalla M. The hope and the hazards of using compliance data in randomized controlled trials. Stat Med. 1998;17:303-317. (Pubitemid 28051100)
45. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967;20:637-648.
46. Newell DJ. Intention-to-treat analysis: implications for quantitative and qualitative research. Int J Epidemiol. 1992;21:837-841.
47. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer. 1976;34:585-612. (Pubitemid 8004970)
48. Lee YJ, Ellenberg JH, Hirtz DG, Nelson KB. Analysis of clinical trials by treatment actually received: is it really an option? Stat Med. 1991 10;1595-1605.
49. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999;319:670-674. (Pubitemid 29423954)
50. Sommer A, Zeger SL. On estimating efficacy from clinical trials. Stat Med. 1991;10:45-52.
51. Rubin DB. More powerful randomization-based p-values in doubleblind trials with non-compliance. Stat Med. 1998;17:371-385. (Pubitemid 28051104)
52. Fergusson D, Aaron SD, Guyatt G, Hebert P. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ. 2002;325:652-654.