Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: The PROPPR randomized clinical trial

JAMA - Journal of the American Medical Association

Volumn 313, Issue 5, 2015, Pages 471-482

  Holcomb, John B ^a   Tilley, Barbara C ^b   Baraniuk, Sarah ^b   Fox, Erin E ^a   Wade, Charles E ^a   Podbielski, Jeanette M ^a   Del Junco, Deborah J ^a   Brasel, Karen J ^c,m   Bulger, Eileen M ^d   Callcut, Rachael A ^e   Cohen, Mitchell Jay ^e   Cotton, Bryan A ^a   Fabian, Timothy C ^f   Inaba, Kenji ^g   Kerby, Jeffrey D ^h   Muskat, Peter ^e,i   O'Keeffe, Terence ^j   Rizoli, Sandro ^k   Robinson, Bryce R H ⁱ   Scalea, Thomas M ^l   Schreiber, Martin A ^m   Stein, Deborah M ^l   Weinberg, Jordan A ^f   Callum, Jeannie L ⁿ   Hess, John R ^d   Matijevic, Nena ^a   Miller, Christopher N ⁱ   Pittet, Jean Francois ^o   Hoyt, David B ^p   Pearson, Gail D ^q   Leroux, Brian ^r   Van Belle, Gerald ^r   more..

^a UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

^b UNIVERSITY OF TEXAS SCHOOL OF PUBLIC HEALTH   (United States)

^c MEDICAL COLLEGE OF WISCONSIN   (United States)

^d UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^g UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^h UNIVERSITY OF ALABAMA SCHOOL OF MEDICINE   (United States)

ⁱ UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^j UNIVERSITY OF ARIZONA   (United States)

^k ST MICHAEL'S HOSPITAL   (Canada)

^l UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^m OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

ⁿ Sunnybrook Health Sciences Centre   (Canada)

^o UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^p AMERICAN COLLEGE OF SURGEONS   (United States)

^q NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

^r UNIVERSITY OF WASHINGTON   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; ARTICLE; BLOOD TRANSFUSION REACTION; CAUSE OF DEATH; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; ERYTHROCYTE TRANSFUSION; EXSANGUINATION; FEMALE; FUNCTIONAL STATUS; HEMOSTASIS; HUMAN; INJURY SEVERITY; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; MULTIPLE ORGAN FAILURE; PATIENT SAFETY; PHASE 3 CLINICAL TRIAL; PLASMA TRANSFUSION; RANDOMIZED CONTROLLED TRIAL; SEPSIS; THROMBOCYTE TRANSFUSION; TREATMENT OUTCOME; VENOUS THROMBOEMBOLISM; BLOOD COMPONENT THERAPY; CLINICAL TRIAL; COMPLICATION; ERYTHROCYTE; PLASMA; PROCEDURES; SHOCK, HEMORRHAGIC; THROMBOCYTE; WOUNDS AND INJURIES;

BLOOD COMPONENT TRANSFUSION; BLOOD PLATELETS; ERYTHROCYTES; EXSANGUINATION; FEMALE; HEMOSTASIS; HUMANS; MALE; PLASMA; SHOCK, HEMORRHAGIC; WOUNDS AND INJURIES;

EID: 84922431269     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2015.12     Document Type: Article

References (61)

1. US Centers for Disease Control and Prevention. Injury prevention and control: data and statistics, 2012. http://webappa.cdc.gov/cgi-bin/broker.exe. Accessed December 21, 2014.
2. Rhee P, Joseph B, Pandit V, et al. Increasing trauma deaths in the United States. Ann Surg. 2014; 260(1):13-21.
3. Tisherman SA, Schmicker RH, Brasel KJ, et al. Detailed description of all deaths in both the Shock and Traumatic Brain Injury Hypertonic Saline Trials of the Resuscitation Outcomes Consortium [published online July 28, 2014]. Ann Surg. doi:10.1097/SLA.0b013e3181df0401.
4. Holcomb JB, Jenkins D, Rhee P, et al. Damage control resuscitation: directly addressing the early coagulopathy of trauma. J Trauma. 2007;62(2):307-310.
5. Holcomb JB, Pati S. Optimal trauma resuscitation with plasma as the primary resuscitative fluid: the surgeon's perspective. Hematology Am Soc Hematol Educ Program. 2013; 2013:656-659.
6. US Army Institute of Surgical Research. Joint Theater Trauma System Clinical Practice Guideline: damage control resuscitation at level IIb and III treatment facilities. http://www.usaisr.amedd.army.mil/assets/cpgs/Damage%20Control%20Resuscitation%20-%201%20Feb%202013.pdf. Accessed December 21, 2014.
7. 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(4):805-813.
8. Shaz BH, Dente CJ, Nicholas J, et al. Increased number of coagulation products in relationship to red blood cell products transfused improves mortality in trauma patients. Transfusion. 2010;50(2):493-500.
9. Cotton BA, Reddy N, Hatch QM, et al. Damage control resuscitation is associated with a reduction in resuscitation volumes and improvement in survival in 390 damage control laparotomy patients. Ann Surg. 2011;254(4):598-605.
10. Holcomb JB, del Junco DJ, Fox EE, et al PROMMTT Study Group. The Prospective, Observational, Multicenter, Major Trauma Transfusion (PROMMTT) study: comparative effectiveness of a time-varying treatment with competing risks. JAMA Surg. 2013;148(2):127-136.
11. Johansson PI, Sørensen AM, Larsen CF, et al. Low hemorrhage-related mortality in trauma patients in a level I trauma center employing transfusion packages and early thromboelastography-directed hemostatic resuscitation with plasma and platelets. Transfusion. 2013;53(12):3088-3099.
12. Langan NR, EckertM, Martin MJ. Changing patterns of in-hospital deaths following implementation of damage control resuscitation practices in US forward military treatment facilities. JAMA Surg. 2014;149(9):904-912.
13. Scalea TM, Bochicchio KM, Lumpkins K, et al. Early aggressive use of fresh frozen plasma does not improve outcome in critically injured trauma patients. Ann Surg. 2008;248(4):578-584.
14. Johnson JL, Moore EE, Kashuk JL, et al. Effect of blood products transfusion on the development of postinjury multiple organ failure. Arch Surg. 2010;145(10):973-977.
15. American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Practice guidelines for perioperative blood transfusion and adjuvant therapies: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Anesthesiology. 2006;105(1):198-208.
16. Dzik WH, Blajchman MA, Fergusson D, et al. Clinical review: Canadian National Advisory Committee on Blood and Blood Products - Massive transfusion consensus conference 2011: report of the panel. Crit Care. 2011;15(6):242.
17. American Society of Anesthesiologists. Standards, guidelines, statements and other documents. https://www.asahq.org/For-Members/Standards-Guidelines-and-Statements.aspx. Accessed September 1, 2014.
18. Spahn DR, Bouillon B, Cerny V, et al. Management of bleeding and coagulopathy following major trauma: an updated European guideline. Crit Care. 2013;17(2):R76.
19. del Junco DJ, Holcomb JB, Fox EE, et al PROMMTT Study Group. Resuscitate early with plasma and platelets or balance blood products gradually: findings from the PROMMTT study. J Trauma Acute Care Surg. 2013;75(1)(suppl 1):S24-S30.
20. Baraniuk S, Tilley BC, del Junco DJ, et al PROPPR Study Group. Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial: Design, rationale and implementation. Injury. 2014; 45(9):1287-1295.
21. US Department of Health and Human Services; US Food and Drug Administration. Guidance for institutional review boards, clinical investigators, and sponsors: exception from informed consent requirements for emergency research, 2013. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM249673.pdf. Accessed September 1, 2014.
22. 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(2):346-352.
23. O'Brien PC. The appropriateness of analysis of variance and multiple-comparison procedures. Biometrics. 1983;39(3):787-794.
24. Baker SP, O'Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974;14(3):187-196.
25. Savage SA, Zarzaur BL, Croce MA, Fabian TC. Redefining massive transfusion when every second counts. J Trauma Acute Care Surg. 2013;74(2):396-400.
26. Farrington CP, Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med. 1990;9(12):1447-1454.
27. Holcomb JB,Wade CE,Michalek JE, et al. Increased plasma and platelet to red blood cell ratios improves outcome in 466 massively transfused civilian trauma patients. Ann Surg. 2008;248(3):447-458.
28. Hollis S. A graphical sensitivity analysis for clinical trials with non-ignorable missing binary outcome. Stat Med. 2002;21(24):3823-3834.
29. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979;35(3):549-556.
30. Klein JP, Moeschberger ML. Survival Analysis: Techniques for Censored and Truncated Data. 2nd ed. New York, NY: Springer; 2003.
31. van Elteren PH. On the combination of independent two-sample tests of Wilcoxon. Bull Int Stat Inst. 1960;37:351-361.
32. Ho AM, Karmakar MK, Dion PW. Are we giving enough coagulation factors during major trauma resuscitation? Am J Surg. 2005;190(3):479-484.
33. Huber-Wagner S, Qvick M, Mussack T, et al Working Group on Polytrauma of German Trauma Society (DGU). Massive blood transfusion and outcome in 1062 polytrauma patients: a prospective study based on the Trauma Registry of the German Trauma Society. Vox Sang. 2007;92(1):69-78.
34. Duchesne JC, Hunt JP, Wahl G, et al. Review of current blood transfusion strategies in a mature level I trauma center: were we wrong for the last 60 years? J Trauma. 2008;65(2):272-276.
35. Sperry JL, Ochoa JB, Gunn SR, et al Inflammation and the Host Response to Injury Investigators. An FFP:PRBC transfusion ratio >/=1:1.5 is associated with a lower risk of mortality after massive transfusion. J Trauma. 2008;65(5):986-993.
36. Johansson PI, Stensballe J. Effect of haemostatic control resuscitation on mortality in massively bleeding patients: a before and after study. Vox Sang. 2009;96(2):111-118.
37. Perkins JG, Cap AP, Spinella PC, et al. An evaluation of the impact of apheresis platelets used in the setting of massively transfused trauma patients [published correction appears in J Trauma. 2009;67(6):1453]. J Trauma. 2009;66(4)(suppl):S77-S84.
38. Holcomb JB, Zarzabal LA,Michalek JE, et al Trauma Outcomes Group. Increased platelet:RBC ratios are associated with improved survival after massive transfusion. J Trauma. 2011;71(2)(suppl 3):S318-S328.
39. Kautza BC, Cohen MJ, Cuschieri J, et al; Inflammation and the Host Response to Injury Investigators. Changes in massive transfusion over time: an early shift in the right direction? J Trauma Acute Care Surg. 2012;72(1):106-111.
40. Radwan ZA, Bai Y, Matijevic N, et al. An emergency department thawed plasma protocol for severely injured patients. JAMA Surg. 2013;148(2):170-175.
41. Robinson BR, Cotton BA, Pritts TA, et al; PROMMTT study group. Application of the Berlin definition in PROMMTT patients: the impact of resuscitation on the incidence of hypoxemia. J Trauma Acute Care Surg. 2013;75(1)(suppl 1):S61-S67.
42. Watson GA, Sperry JL, RosengartMR, et al Inflammation and Host Response to Injury Investigators. Fresh frozen plasma is independently associated with a higher risk of multiple organ failure and acute respiratory distress syndrome. J Trauma. 2009;67(2):221-227.
43. Roback JD, Caldwell S, Carson J, et al American Association for the Study of Liver; American Academy of Pediatrics; US Army; American Society of Anesthesiology; American Society of Hematology. Evidence-based practice guidelines for plasma transfusion. Transfusion. 2010;50(6):1227-1239.
44. Pieracci FM, Kashuk JL, Moore EE. Postinury hemotherapy and hemostasis. In: Mattox KL, Moore EE, Feliciano DV, eds. Trauma. 7th ed. New York, NY: McGraw-Hill; 2012:216-235.
45. Kelly JM, Callum JL, Rizoli SB. 1:1:1-warranted or wasteful? even where appropriate, high ratio transfusion protocols are costly: early transition to individualized care benefits patients and transfusion services. Expert Rev Hematol. 2013;6(6):631-633.
46. Park PK, Cannon JW, YeW, et al. Transfusion strategies and development of acute respiratory distress syndrome in combat casualty care. J Trauma Acute Care Surg. 2013;75(2)(suppl 2):S238-S246.
47. Sauaia A, Moore EE, Johnson JL, et al. Temporal trends of postinjury multiple-organ failure: still resource intensive, morbid, and lethal. J Trauma Acute Care Surg. 2014;76(3):582-592.
48. Nascimento B, Callum J, Tien H, et al. Effect of a fixed-ratio (1:1:1) transfusion protocol versus laboratory-results-guided transfusion in patients with severe trauma: a randomized feasibility trial. CMAJ. 2013;185(12):583-589.
49. Johansson PI, Stensballe J, Oliveri R,Wade CE, Ostrowski SR, Holcomb JB. How I treat patients with massive hemorrhage. Blood. 2014;124(20):3052-3058.
50. Hoyt DB, Bulger EM, Knudson MM, et al. Death in the operating room: an analysis of a multi-center experience. J Trauma. 1994;37(3):426-432.
51. Bulger EM, May S, Kerby JD, et al ROC Investigators. Out-of-hospital hypertonic resuscitation after traumatic hypovolemic shock: a randomized, placebo controlled trial. Ann Surg. 2011;253(3):431-441.
52. Sarode R, Milling TJ Jr, Refaai MA, et al. Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study. Circulation. 2013;128(11):1234-1243.
53. US Food and Drug Administration. Product development program for interventions in patients with severe bleeding due to trauma or other causes, 2010. http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm241913.htm. Accessed December 21, 2014.
54. Holcomb JB,Weiskopf R, Champion H, et al. Challenges to effective research in acute trauma resuscitation: consent and endpoints. Shock. 2011; 35(2):107-113.
55. Moore EE, Moore FA, Fabian TC, et al; PolyHeme Study Group. Human polymerized hemoglobin for the treatment of hemorrhagic shock when blood is unavailable: the USA multicenter trial. J AmColl Surg. 2009;208(1):1-13.
56. Hauser CJ, Boffard K, Dutton R, et al CONTROL Study Group. Results of the CONTROL trial: efficacy and safety of recombinant activated factor VII in the management of refractory traumatic hemorrhage. J Trauma. 2010;69(3):489-500.
57. Silverman T, Aebersold P, Landow L, Lindsey K. Regulatory perspectives on clinical trials for trauma, transfusion, and hemostasis. Transfusion. 2005;45(1)(suppl):14S-21S.
58. 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(5):467-479.
59. 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(2):358-362.
60. Ho AM, Dion PW, Yeung JH, et al. Prevalence of survivor bias in observational studies on fresh frozen plasma:erythrocyte ratios in trauma requiring massive transfusion. Anesthesiology. 2012;116(3):716-728.
61. del Junco DJ, Fox EE, Camp EA, Rahbar MH, Holcomb JB; PROMMTT Study Group. Seven deadly sins in trauma outcomes research: an epidemiologic post mortem for major causes of bias. J Trauma Acute Care Surg. 2013;75(1)(suppl 1):S97-S103.