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Emergency Resuscitation of Patients Enrolled in the US Diaspirin Cross-linked Hemoglobin (DCLHb) Clinical Efficacy Trial

Published online by Cambridge University Press:  15 December 2014

Edward P. Sloan*
Affiliation:
Department of Emergency Medicine, University of Illinois at Chicago, Chicago, IllinoisUSA
Max Koenigsberg
Affiliation:
Advocate Illinois Masonic Medical Center, Chicago, IllinoisUSA
W. Brad Weir
Affiliation:
Carle Physician Group, Department of Emergency Medicine, University of Illinois College of Medicine at Urbana-Champaign, Urbana-Champaign, IllinoisUSA
James M. Clark
Affiliation:
Rush Medical College, Rush University Medical Center, Chicago, IllinoisUSA
Robert O'Connor
Affiliation:
Department of Emergency Medicine, University of Virginia, Charlottesville, VirginiaUSA
Michael Olinger
Affiliation:
Department of Emergency Medicine, Indiana University, Indianapolis, IndianaUSA
Rita Cydulka
Affiliation:
Department of Emergency Medicine, Case Western Reserve University, Cleveland, OhioUSA
*
Correspondence: Edward P. Sloan, MD, MPH Department of Emergency Medicine University of Illinois College of Medicine Mail Code 724 Room 471H CME 808 South Wood Street Chicago, Illinois 60612 USA E-mail [email protected]

Abstract

Introduction

Optimal emergent management of traumatic hemorrhagic shock patients requires a better understanding of treatment provided in the prehospital/Emergency Medical Services (EMS) and emergency department (ED) settings.

Hypothesis/Problem

Described in this research are the initial clinical status, airway management, fluid and blood infusions, and time course of severely-injured hemorrhagic shock patients in the EMS and ED settings from the diaspirin cross-linked hemoglobin (DCLHb) clinical trial.

Methods

Data were analyzed from 17 US trauma centers gathered during a randomized, controlled, single-blinded efficacy trial of a hemoglobin solution (DCLHb) as add-on therapy versus standard therapy.

Results

Among the 98 randomized patients, the mean EMS Glasgow Coma Scale (GCS) was 10.6 (SD = 5.0), the mean EMS revised trauma score (RTS) was 6.3 (SD = 1.9), and the mean injury severity score (ISS) was 31 (SD = 17). Upon arrival to the ED, the GCS was 20% lower (7.8 (SD = 5.3) vs 9.7 (SD = 6.3)) and the RTS was 12% lower (5.3 (SD = 2.0) vs 6.0 (SD = 2.1)) than EMS values in blunt trauma patients (P < .001). By ED disposition, 80% of patients (78/98) were intubated. Rapid sequence intubation (RSI) was utilized in 77% (60/78), most often utilizing succinylcholine (65%) and midazolam (50%). The mean crystalloid volume infused was 4.2 L (SD = 3.4 L), 80% of which was infused within the ED. Emergency department blood transfusion occurred in 62% of patients, with an average transfused volume of 1.2 L (SD = 2.0 L). Blunt trauma patients received 2.1 times more total fluids (7.4 L vs 3.5 L, < .001) and 2.4 times more blood (2.4 L vs 1.0 L, P < .001). The mean time of patients taken from injury site to operating room (OR) was 113 minutes (SD = 87 minutes). Twenty-one (30%) of the 70 patients taken to the OR from the ED were sent within 60 minutes of the estimated injury time. Penetrating trauma patients were taken to the OR 52% sooner than blunt trauma patients (72 minutes vs 149 minutes, P < .001).

Conclusion

Both GCS and RTS decreased prior to ED arrival in blunt trauma patients. Intubation was performed using RSI, and crystalloid infusion of three times the estimated blood loss volume (L) and blood transfusion of the estimated blood loss volume (L) were provided in the EMS and ED settings. Surgical intervention for these trauma patients most often occurred more than one hour from the time of injury. Penetrating trauma patients received surgical intervention more rapidly than those with a blunt trauma mechanism.

SloanEP, KoenigsbergM, WeirWB, ClarkJM, O'ConnorR, OlingerM, CydulkaR. Emergency Resuscitation of Patients Enrolled in the US Diaspirin Cross-linked Hemoglobin (DCLHb) Clinical Efficacy Trial. Prehosp Disaster Med. 2015;30(1):1-8.

Type
Original Research
Copyright
Copyright © World Association for Disaster and Emergency Medicine 2014 

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Footnotes

Conflicts of interest: none

References

1. Teixeira, PG, Inaba, K, Hadjizacharia, P, et al. Preventable or potentially preventable mortality at a mature trauma center. J Trauma. 2007;63(6):1338-1346; discussion 1346-1337.Google ScholarPubMed
2. Cherkas, D. Traumatic hemorrhagic shock: advances in fluid management. Emerg Med Pract. 2011;13(11):1-19; quiz 19-20.Google ScholarPubMed
3. Reines, HD, Bartlett, RL, Chudy, NE, et al. Is advanced life support appropriate for victims of motor vehicle accidents: the South Carolina Highway Trauma Project. J Trauma. 1988;28(5):563-570.Google Scholar
4. Fowler, R, Pepe, PE. Prehospital care of the patient with major trauma. Emerg Med Clin North Am. 2002;20(4):953-974.CrossRefGoogle ScholarPubMed
5. Eastridge, BJ, Mabry, RL, Seguin, P, et al. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg. 2012;73(6 Suppl 5):S431-437.CrossRefGoogle ScholarPubMed
6. Yeguiayan, JM, Garrigue, D, Binquet, C, et al. Medical pre-hospital management reduces mortality in severe blunt trauma: a prospective epidemiological study. Crit Care. 2011;15(1):R34.Google Scholar
7. Nolan, J. Fluid resuscitation for the trauma patient. Resuscitation. 2001;48(1):57-69.Google Scholar
8. Trunkey, DD. Prehospital fluid resuscitation of the trauma patient. An analysis and review. Emerg Med Serv. 2001;30(5):93-95;, 96, 98 passim.Google Scholar
9. Rodricks, MB, Deutschman, CS. Emergent airway management. Indications and methods in the face of confounding conditions. Crit Care Clin. 2000;16(3):389-409.CrossRefGoogle ScholarPubMed
10. Kerby, JD, Cusick, MV. Prehospital emergency trauma care and management. Surg Clin North Am. 2012;92(4):823-841, vii.CrossRefGoogle ScholarPubMed
11. Gofrit, ON, Leibovici, D, Shemer, J, et al. Ketamine in the field: the use of ketamine for induction of anaesthesia before intubation in injured patients in the field. Injury. 1997;28(1):41-43.Google Scholar
12. Graham, CA, Meyer, AD. Prehospital emergency rapid sequence induction of anaesthesia. J Accid Emerg Med. 1997;14(4):219-221.Google Scholar
13. Hedges, JR, Dronen, SC, Feero, S, et al. Succinylcholine-assisted intubations in prehospital care. Ann Emerg Med. 1988;17(5):469-472.Google Scholar
14. Lowe, L, Sagehorn, K, Madsen, R. The effect of a rapid sequence induction protocol on intubation success rate in an air medical program. Air Med J. 1998;17(3):101-104.Google Scholar
15. Rhee, KJ, O'Malley, RJ. Neuromuscular blockade-assisted oral intubation versus nasotracheal intubation in the prehospital care of injured patients. Ann Emerg Med. 1994;23(1):37-42.Google Scholar
16. Sing, RF, Rotondo, MF, Zonies, DH, et al. Rapid sequence induction for intubation by an aeromedical transport team: a critical analysis. Am J Emerg Med. 1998;16(6):598-602.Google Scholar
17. Syverud, SA, Borron, SW, Storer, DL, et al. Prehospital use of neuromuscular blocking agents in a helicopter ambulance program. Ann Emerg Med. 1988;17(3):236-242.Google Scholar
18. Wayne, MA, Friedland, E. Prehospital use of succinylcholine: a 20-year review. Prehosp Emerg Care. 1999;3(2):107-109.CrossRefGoogle ScholarPubMed
19. Pace, SA, Fuller, FP. Out-of-hospital succinylcholine-assisted endotracheal intubation by paramedics. Ann Emerg Med. 2000;35(6):568-572.Google Scholar
20. Wang, HE, O'Connor, RE, Megargel, RE, et al. The utilization of midazolam as a pharmacologic adjunct to endotracheal intubation by paramedics. Prehosp Emerg Care. 2000;4(1):14-18.CrossRefGoogle ScholarPubMed
21. Dickinson, ET, Cohen, JE, Mechem, CC. The effectiveness of midazolam as a single pharmacologic agent to facilitate endotracheal intubation by paramedics. Prehosp Emerg Care. 1999;3(3):191-193.Google Scholar
22. Norwood, S, Myers, MB, Butler, TJ. The safety of emergency neuromuscular blockade and orotracheal intubation in the acutely injured trauma patient. J Am Coll Surg. 1994;179(6):646-652.Google Scholar
23. Talucci, RC, Shaikh, KA, Schwab, CW. Rapid sequence induction with oral endotracheal intubation in the multiply injured patient. Am Surg. 1988;54(4):185-187.Google Scholar
24. McNicholl, BP. The golden hour and prehospital trauma care. Injury. 1994;25(4):251-254.Google Scholar
25. Meighan, A, Gregori, A, Kelly, M, et al. Pelvic fractures: the golden hour. Injury. 1998;29(3):211-213.Google Scholar
26. David, JS, Spann, C, Marcotte, G, et al. Haemorrhagic shock, therapeutic management. Ann Fr Anesth Reanim. 2013;32(7-8):497-503.Google Scholar
27. Hubetamann, B, Lefering, R, Taeger, G, et al. Influence of prehospital fluid resuscitation on patients with multiple injuries in hemorrhagic shock in patients from the DGU trauma registry. J Emerg Trauma Shock. 2011;4(4):465-471.Google Scholar
28. Geeraedts, LM Jr., Kaasjager, HA, van Vugt, AB, et al. Exsanguination in trauma: a review of diagnostics and treatment options. Injury. 2009;40(1):11-20.CrossRefGoogle ScholarPubMed
29. Beekley, AC. Damage control resuscitation: a sensible approach to the exsanguinating surgical patient. Crit Care Med. 2008;36(7 Suppl):S267-274.Google Scholar
30. 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.Google Scholar
31. Duchesne, JC, McSwain, NE Jr., Cotton, BA, et al. Damage control resuscitation: the new face of damage control. J Trauma. 2010;69(4):976-990.Google Scholar
32. McDermott, FT, Cordner, SM, Cooper, DJ, et al. Management deficiencies and death preventability of road traffic fatalities before and after a new trauma care system in Victoria, Australia. J Trauma. 2007;63(2):331-338.Google Scholar
33. Seamon, MJ, Fisher, CA, Gaughan, J, et al. Prehospital procedures before emergency department thoracotomy: “scoop and run” saves lives. J Trauma. 2007;63(1):113-120.Google Scholar
34. MacKenzie, EJ, Rivara, FP, Jurkovich, GJ, et al. A national evaluation of the effect of trauma-center care on mortality. N Engl J Med. 2006;354(4):366-378.Google Scholar
35. Sloan, EP, Koenigsberg, M, Brunett, PH, et al. Post hoc mortality analysis of the efficacy trial of diaspirin cross-linked hemoglobin in the treatment of severe traumatic hemorrhagic shock. J Trauma. 2002;52(5):887-895.Google Scholar
36. Sloan, EP, Koenigsberg, M, Gens, D, et al. Diaspirin cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemorrhagic shock: a randomized controlled efficacy trial. Jama. 1999;282(19):1857-1864.Google Scholar
37. Sloan, EP, Koenigsberg, M, Houghton, J, et al. The informed consent process and the use of the exception to informed consent in the clinical trial of diaspirin cross-linked hemoglobin (DCLHb) in severe traumatic hemorrhagic shock. DCLHb Traumatic Hemorrhagic Shock study group. Acad Emerg Med. 1999;6(12):1203-1209.Google Scholar
38. Champion, HR, Sacco, WJ, Copes, WS, et al. A revision of the Trauma Score. J Trauma. 1989;29(5):623-629.Google Scholar
39. Cales, RH. Trauma mortality in Orange County: the effect of implementation of a regional trauma system. Ann Emerg Med. 1984;13(1):1-10.Google Scholar
40. Harris, T, Davenport, R, Hurst, T, et al. Improving outcome in severe trauma: trauma systems and initial management: intubation, ventilation, and resuscitation. Postgrad Med J. 2012;88(1044):588-594.Google Scholar
41. Jorden, RC. Airway management. Emerg Med Clin North Am. 1988;6(4):671-686.Google Scholar
42. Champion, HR, Copes, WS, Sacco, WJ, et al. The Major Trauma Outcome Study: establishing national norms for trauma care. J Trauma. 1990;30(11):1356-1365.CrossRefGoogle ScholarPubMed
43. Ertmer, C, Kampmeier, T, Rehberg, S, et al. Fluid resuscitation in multiple trauma patients. Curr Opin Anaesthesiol. 2011;24(2):202-208.Google Scholar
44. Lairet, JR, Bebarta, VS, Burns, CJ, et al. Prehospital interventions performed in a combat zone: a prospective multicenter study of 1,003 combat wounded. J Trauma Acute Care Surg. 2012;73(2 Suppl 1):S38-42.CrossRefGoogle Scholar
45. McQueen, C, Crombie, N, Hulme, J, et al. Prehospital anaesthesia performed by physician/critical care paramedic teams in a major trauma network in the UK: a 12 month review of practice. Emerg Med J. 2013.Google Scholar
46. Perkins, ZB, Gunning, M, Crilly, J, et al. The haemodynamic response to pre-hospital RSI in injured patients. Injury. 2013;44(5):618-623.Google Scholar
47. Rose, WD, Anderson, LD, Edmond, SA. Analysis of intubations. Before and after establishment of a rapid sequence intubation protocol for air medical use. Air Med J. 1994;13(11-12):475-478.Google Scholar
48. Ballow, SL, Kaups, KL, Anderson, S, et al. A standardized rapid sequence intubation protocol facilitates airway management in critically injured patients. J Trauma Acute Care Surg. 2012;73(6):1401-1405.Google Scholar
49. Wyen, H, Lefering, R, Maegele, M, et al. The golden hour of shock—how time is running out: prehospital time intervals in Germany--a multivariate analysis of 15,103 patients from the TraumaRegister DGU(R). Emerg Med J. 2013;30(12):1048-1055.Google Scholar
50. Dinh, MM, Bein, K, Roncal, S, et al. Redefining the golden hour for severe head injury in an urban setting: the effect of prehospital arrival times on patient outcomes. Injury. 2013;44(5):606-610.Google Scholar
51. Oswalt, JL, Hedges, JR, Soifer, BE, et al. Analysis of trauma intubations. Am J Emerg Med. 1992;10(6):511-514.Google Scholar
52. Cushman, JT, Zachary Hettinger, A, et al. Effect of intensive physician oversight on a prehospital rapid-sequence intubation program. Prehosp Emerg Care. 2010;14(3):310-316.Google Scholar
53. Davis, DP, Kimbro, TA, Vilke, GM. The use of midazolam for prehospital rapid-sequence intubation may be associated with a dose-related increase in hypotension. Prehosp Emerg Care. 2001;5(2):163-168.Google Scholar
54. Bergen, JM, Smith, DC. A review of etomidate for rapid sequence intubation in the emergency department. J Emerg Med. 1997;15(2):221-230.Google Scholar
55. Stollings, JL, Diedrich, DA, Oyen, LJ, et al. Rapid-sequence intubation: a review of the process and considerations when choosing medications. Ann Pharmacother. 2014;48(1):62-76.Google Scholar
56. Orebaugh, SL. Succinylcholine: adverse effects and alternatives in emergency medicine. Am J Emerg Med. 1999;17(7):715-721.Google Scholar
57. McCourt, KC, Salmela, L, Mirakhur, RK, et al. Comparison of rocuronium and suxamethonium for use during rapid sequence induction of anaesthesia. Anaesthesia. 1998;53(9):867-871.Google Scholar
58. Sakuraba, S, Serita, R, Kosugi, S, et al. Pretreatment with magnesium sulphate is associated with less succinylcholine-induced fasciculation and subsequent tracheal intubation-induced hemodynamic changes than precurarization with vecuronium during rapid sequence induction. Acta Anaesthesiol Belg. 2006;57(3):253-257.Google Scholar
59. Fleming, NW, Chung, F, Glass, PS, et al. Comparison of the intubation conditions provided by rapacuronium (ORG 9487) or succinylcholine in humans during anesthesia with fentanyl and propofol. Anesthesiology. 1999;91(5):1311-1317.CrossRefGoogle ScholarPubMed
60. Vijayakumar, E, Bosscher, H, Renzi, FP, et al. The use of neuromuscular blocking agents in the emergency department to facilitate tracheal intubation in the trauma patient: help or hindrance? J Crit Care. 1998;13(1):1-6.Google Scholar
61. Sehdev, RS, Symmons, DA, Kindl, K. Ketamine for rapid sequence induction in patients with head injury in the emergency department. Emerg Med Australas. 2006;18(1):37-44.CrossRefGoogle ScholarPubMed
62. Sih, K, Campbell, SG, Tallon, JM, et al. Ketamine in adult emergency medicine: controversies and recent advances. Ann Pharmacother. 2011;45(12):1525-1534.Google Scholar
63. Scherzer, D, Leder, M, Tobias, JD. Pro-con debate: etomidate or ketamine for rapid sequence intubation in pediatric patients. J Pediatr Pharmacol Ther. 2012;17(2):142-149.Google Scholar
64. Cotton, BA, Jerome, R, Collier, BR, et al. Guidelines for prehospital fluid resuscitation in the injured patient. J Trauma. 2009;67(2):389-402.Google Scholar
65. Bickell, WH, Wall, MJ Jr., Pepe, PE, et al. Immediate versus delayed fluid resuscitation for hypotensive patients with penetrating torso injuries. N Engl J Med. 1994;331(17):1105-1109.Google Scholar
66. Hampton, DA, Fabricant, LJ, Differding, J, et al. Prehospital intravenous fluid is associated with increased survival in trauma patients. J Trauma Acute Care Surg. 2013;75(1 Suppl 1):S9-15.CrossRefGoogle ScholarPubMed
67. Annane, D, Siami, S, Jaber, S, et al. Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: the CRISTAL randomized trial. Jama. 2013;310(17):1809-1817.Google Scholar
68. Bulger, EM, May, S, Kerby, JD, et al. Out-of-hospital hypertonic resuscitation after traumatic hypovolemic shock: a randomized, placebo controlled trial. Ann Surg. 2011;253(3):431-441.Google Scholar
69. Cooper, DJ, Myles, PS, McDermott, FT, et al. Prehospital hypertonic saline resuscitation of patients with hypotension and severe traumatic brain injury: a randomized controlled trial. Jama. 2004;291(11):1350-1357.Google Scholar
70. Duke, MD, Guidry, C, Guice, J, et al. Restrictive fluid resuscitation in combination with damage control resuscitation: time for adaptation. J Trauma Acute Care Surg. 2012;73(3):674-678.CrossRefGoogle ScholarPubMed
71. Rizoli, SB, Rhind, SG, Shek, PN, et al. The immunomodulatory effects of hypertonic saline resuscitation in patients sustaining traumatic hemorrhagic shock: a randomized, controlled, double-blinded trial. Ann Surg. 2006;243(1):47-57.CrossRefGoogle ScholarPubMed
72. Swaroop, M, Straus, DC, Agubuzu, O, et al. Prehospital transport times and survival for hypotensive patients with penetrating thoracic trauma. J Emerg Trauma Shock. 2013;6(1):16-20.Google Scholar
73. Sampalis, JS, Lavoie, A, Williams, JI, et al. Impact of on-site care, prehospital time, and level of in-hospital care on survival in severely-injured patients. J Trauma. 1993;34(2):252-261.Google Scholar
74. Rahbar, E, Fox, EE, del Junco, DJ, et al. Early resuscitation intensity as a surrogate for bleeding severity and early mortality in the PROMMTT study. J Trauma Acute Care Surg. 2013;75(1 Suppl 1):S16-23.CrossRefGoogle ScholarPubMed
75. Yaghoubian, A, Lewis, RJ, Putnam, B, et al. Reanalysis of prehospital intravenous fluid administration in patients with penetrating truncal injury and field hypotension. Am Surg. 2007;73(10):1027-1030.Google Scholar
76. Reah, G, Bodenham, AR, Mallick, A, et al. Initial evaluation of diaspirin cross-linked hemoglobin (DCLHb) as a vasopressor in critically ill patients. Crit Care Med. 1997;25(9):1480-1488.Google Scholar
77. Doran, JV, Tortella, BJ, Drivet, WJ, et al. Factors influencing successful intubation in the prehospital setting. Prehosp Disaster Med. 1995;10(4):259-264.Google Scholar
78. Przybelski, RJ, Daily, EK, Kisicki, JC, et al. Phase I study of the safety and pharmacologic effects of diaspirin cross-linked hemoglobin solution. Crit Care Med. 1996;24(12):1993-2000.Google Scholar
79. Sloan, EP, Philbin, NB, Koenigsberg, MD, et al. The Lack of Consistent DCLHb Infusion Blood Pressure Effects in the US and EU Traumatic Hemorrhagic Shock Clinical Trials. Shock. 2010;33(2):123-133.Google Scholar
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