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The Use of the Revised Trauma Score as an Entry Criterion in Traumatic Hemorrhagic Shock Studies: Data from the DCLHb Clinical Trials

Published online by Cambridge University Press:  30 July 2012

Edward P. Sloan ,
Max Koenigsberg ,
James M. Clark  and
Amol Desai
Edward P. Sloan*
Affiliation:
Department of Emergency Medicine, University of Illinois at Chicago, Chicago, Illinois USA
Max Koenigsberg
Affiliation:
Advocate Illinois Masonic Medical Center, Chicago, Illinois USA
James M. Clark
Affiliation:
Rush Medical College, Rush University Medical Center, Chicago, Illinois USA
Amol Desai
Affiliation:
Department of Emergency Medicine, University of Arizona, Tucson, Arizona USA
*
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]
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Abstract

Introduction

The Revised Trauma Score (RTS) has been proposed as an entry criterion to identify patients with mid-range survival probability for traumatic hemorrhagic shock studies.

Hypothesis/Problem

Determination of which of four RTS strata (1-3.99, 2-4.99, 1-4.99, and 2-5.99) identifies patients with predicted and actual mortality rates near 50% for use as an entry criterion in traumatic hemorrhagic shock clinical trials.

Methods

Existing database analysis in which demographic and injury severity data from two prior international Diaspirin Cross-Linked Hemoglobin (DCLHb) clinical trials were used to identify an RTS range that could be an optimal entry criterion in order to find the population of trauma patients with mid-range predicted and actual mortality rates.

Results

Of 208 study patients, the mean age was 37 years, 65% sustained blunt trauma, 49% received DCLHb, and 57% came from the European Union study arm. The mean values were: ISS, 31 (SD = 18); RTS, 5.6 (SD = 1.8); and Glasgow Coma Scale (GCS), 10.4 (SD = 4.8). The mean TRISS-predicted mortality was 34% and the actual 28-day mortality was 35%. The initially proposed 1-3.99 RTS range (n = 41) had the highest predicted (79%) and actual (71%) mortality rates. The 2-5.99 RTS range (n = 79) had a 62% predicted and 53% actual mortality, and included 76% blunt trauma patients. Removal of GCS <5 patients from this RTS 2-5.99 subgroup caused a 48% further reduction in eligible patients, leaving 41 patients (20% of 208 total patients), 66% of whom sustained a blunt trauma injury. This subgroup had 54% predicted and 49% actual mortality rates. Receiver operator curve (ROC) analysis found the GCS to be as predictive of mortality as the RTS, both in the total patient population and in the RTS 2-5.99 subgroup.

Conclusion

The use of an RTS 2-5.99 inclusion criterion range identifies a traumatic hemorrhagic shock patient subgroup with predicted and actual mortality that approach the desired 50% rate. The exclusion of GCS <5 from this RTS 2-5.99 subgroup patients yields a smaller, more uniform patient subgroup whose mortality is more likely related to hemorrhagic shock than traumatic brain injury. Future studies should examine whether the RTS or other physiologic criteria such as the GCS score are most useful as traumatic hemorrhagic shock study entry criteria.

Sloan EP, Koenigsberg M, Clark JM, Desai A. The use of the Revised Trauma Score as an entry criterion in traumatic hemorrhagic shock studies: data from the DCLHb clinical trials. Prehosp Disaster Med. 2012;27(4):1-15.

Keywords

clinical trialdiaspirin cross-linked hemoglobin (DCLHb)entry criteriaexclusion criteriaGlasgow Coma Scale (GCS)mid-range mortalityRevised Trauma Score (RTS)traumatic hemorrhagic shock resuscitation
Type
Original Research
Information
Prehospital and Disaster Medicine , Volume 27 , Issue 4 , August 2012 , pp. 330 - 344
Copyright
Copyright © World Association for Disaster and Emergency Medicine 2012

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References

1. Krausz, MM. Controversies in shock research: hypertonic resuscitation--pros and cons. Shock. 1995;3(1):69-72.Google ScholarPubMed
2. Sauaia, A, Moore, FA, Moore, EE, et al. . Epidemiology of trauma deaths: a reassessment. J Trauma. 1995;38(2):185-193.Google Scholar
3. 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(5):528-533.CrossRefGoogle ScholarPubMed
4. Kauvar, DS. Wade CE. The epidemiology and modern management of traumatic hemorrhage: US and international perspectives. Crit Care. 2005;9 Suppl 5:S1-9.CrossRefGoogle ScholarPubMed
5. Duranteau, J, Harrois, A. Hemorrhagic shock [in French]. Rev Prat. 2006;56(8):849-857.Google ScholarPubMed
6. Rossaint, R, Cerny, V, Coats, TJ, et al. . Key issues in advanced bleeding care in trauma. Shock. 2006;26(4):322-331.CrossRefGoogle ScholarPubMed
7. Jahr, JS, Walker, V, Manoochehri, K. Blood substitutes as pharmacotherapies in clinical practice. Curr Opin Anaesthesiol. 2007;20(4):325-330.Google Scholar
8. Winslow, RM. Cell-free oxygen carriers: scientific foundations, clinical development, and new directions. Biochim Biophys Acta. 2008;1784(10):1382-1386.Google Scholar
9. Moore, EE, Johnson, JL, Moore, FA, Moore, HB. The USA Multicenter Prehospital Hemoglobin-based Oxygen Carrier Resuscitation Trial: scientific rationale, study design, and results. Crit Care Clin. 2009;25(2):325-356, Table of Contents.Google Scholar
10. Freilich, D, Pearce, LB, Pitman, A, et al. . HBOC-201 vasoactivity in a phase III clinical trial in orthopedic surgery subjects--extrapolation of potential risk for acute trauma trials. J Trauma. 2009;66(2):365-376.Google Scholar
11. Riou, B, Landais, P, Vivien, B, et al. . Distribution of the probability of survival is a strategic issue for randomized trials in critically ill patients. Anesthesiology. 2001;95(1):56-63.Google Scholar
12. Dellinger, RP, Vincent, JL, Marshall, J, Reinhart, K. Important issues in the design and reporting of clinical trials in severe sepsis and acute lung injury. J Crit Care. 2008;23(4):493-499.CrossRefGoogle ScholarPubMed
13. George, SL. Statistical issues in translational cancer research. Clin Cancer Res. 2008;14(19):5954-5958.Google Scholar
14. Kerner, T, Ahlers, O, Veit, S, Riou, B, Saunders, M, Pison, U. DCL-Hb for trauma patients with severe hemorrhagic shock: the European “On-Scene” multicenter study. Intensive Care Med. 2003;29(3):378-385.CrossRefGoogle ScholarPubMed
15. Moore, L, Lavoie, A, Turgeon, AF, et al. . The trauma risk adjustment model: a new model for evaluating trauma care. Ann Surg. 2009;249(6):1040-1046.Google Scholar
16. Mongan, PD, Moon-Massat, PF, Rentko, V, Mihok, S, Dragovich, A, Sharma, P. Regional blood flow after serial normovolemic exchange transfusion with HBOC-201 (Hemopure) in anesthetized swine. J Trauma. 2009;67(1):51-60.Google ScholarPubMed
17. Freilich, D , NMRC. Review of a Proposed Clinical Trial of HBOC-201 in Trauma. December 14, 2006.Google Scholar
18. Marinaro, J, Smith, J, Tawil, I, Billstrand, M, Crookston, KP. HBOC-201 use in traumatic brain injury: case report and review of literature. Transfusion. 2009;49(10):2054-2059.CrossRefGoogle ScholarPubMed
19. Jahr, JS, Mackenzie, C, Pearce, LB, Pitman, A, Greenburg, AG. HBOC-201 as an alternative to blood transfusion: efficacy and safety evaluation in a multicenter phase III trial in elective orthopedic surgery. J Trauma. 2008;64(6):1484-1497.Google Scholar
20. Champion, HR, Sacco, WJ, Copes, WS, Gann, DS, Gennarelli, TA, Flanagan, ME. A revision of the Trauma Score. J Trauma. 1989;29(5):623-629.CrossRefGoogle ScholarPubMed
21. Gabbe, BJ, Cameron, PA, Finch, CF. Is the revised trauma score still useful? ANZ J Surg. 2003;73(11):944-948.Google Scholar
22. Guzzo, JL, Bochicchio, GV, Napolitano, LM, Malone, DL, Meyer, W, Scalea, TM. Prediction of outcomes in trauma: anatomic or physiologic parameters? J Am Coll Surg. 2005;201(6):891-897.Google Scholar
23. Esme, H, Solak, O, Yurumez, Y, et al. . The prognostic importance of trauma scoring systems for blunt thoracic trauma. Thorac Cardiovasc Surg. 2007;55(3):190-195.CrossRefGoogle ScholarPubMed
24. Lichtveld, RA, Spijkers, AT, Hoogendoorn, JM, Panhuizen, IF, van der Werken, C. Triage Revised Trauma Score change between first assessment and arrival at the hospital to predict mortality. Int J Emerg Med. 2008;1(1):21-26.Google Scholar
25. Ahmad, HN. Evaluation of revised trauma score in polytraumatized patients. J Coll Physicians Surg Pak. 2004;14(5):286-289.Google Scholar
26. 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
27. Boyd, CR, Tolson, MA, Copes, WS. Evaluating trauma care: the TRISS method. Trauma Score and the Injury Severity Score. J Trauma. 1987;27(4):370-378.Google ScholarPubMed
28. Moore, EE, Johnson, JL, Cheng, AM, Masuno, T, Banerjee, A. Insights from studies of blood substitutes in trauma. Shock. 2005;24(3):197-205.Google Scholar
29. Carmichael, FJ, Ali, AC, Campbell, JA, et al. . A phase I study of oxidized raffinose cross-linked human hemoglobin. Crit Care Med. 2000;28(7):2283-2292.Google Scholar
30. Alayash, AI, D'Agnillo, F, Buehler, PW. First-generation blood substitutes: what have we learned? Biochemical and physiological perspectives. Expert Opin Biol Ther. 2007;7(5):665-675.Google Scholar
31. Peelen, L, Peek, N, de Jonge, E, Scheffer, GJ, de Keizer, NF. The use of a registry database in clinical trial design: assessing the influence of entry criteria on statistical power and number of eligible patients. Int J Med Inform. 2007;76(2-3):176-183.CrossRefGoogle ScholarPubMed
32. Atroshi, I, McCabe, SJ. The early steps in clinical research: importance of entry criteria and true randomization. J Hand Surg Am. 1998;23(4):759-761.Google Scholar
33. Buyse, ME. The case of loose inclusion criteria in clinical trials. Acta Chir Belg. 1990;90(3):129-131.Google Scholar
34. McMahon, AD. Study control, violators, inclusion criteria and defining explanatory and pragmatic trials. Stat Med. 2002;21(10):1365-1376.CrossRefGoogle ScholarPubMed
35. Rehn, M, Eken, T, Kruger, AJ, Steen, PA, Skaga, NO, Lossius, HM. Precision of field triage in patients brought to a trauma centre after introducing trauma team activation guidelines. Scand J Trauma Resusc Emerg Med. 2009;17:1.CrossRefGoogle ScholarPubMed
36. Giannakopoulos, GF, Saltzherr, TP, Lubbers, WD, et al. . Is a maximum Revised Trauma Score a safe triage tool for Helicopter Emergency Medical Services cancellations? Eur J Emerg Med. 2011;18(4):197-201.Google Scholar
37. Sartorius, D, Le Manach, Y, David, JS, et al. . Mechanism, glasgow coma scale, age, and arterial pressure (MGAP): a new simple prehospital triage score to predict mortality in trauma patients. Crit Care Med. 2010;38(3):831-837.CrossRefGoogle ScholarPubMed
38. Sperry, JL, Ochoa, JB, Gunn, SR, et al. . 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./=1:1.5+is+associated+with+a+lower+risk+of+mortality+after+massive+transfusion.+J+Trauma.+2008;65(5):986-993.>Google Scholar
39. Sperry, JL, Frankel, HL, Vanek, SL, et al. . Early hyperglycemia predicts multiple organ failure and mortality but not infection. J Trauma. 2007;63(3):487-493; discussion 493-484.Google Scholar
40. Dutton, RP, Mackenzie, CF, Scalea, TM. Hypotensive resuscitation during active hemorrhage: impact on in-hospital mortality. J Trauma. 2002;52(6):1141-1146.Google Scholar
41. Moore, EE, Moore, FA, Fabian, TC, et al. . Human polymerized hemoglobin for the treatment of hemorrhagic shock when blood is unavailable: the USA multicenter trial. J Am Coll Surg. 2009;208(1):1-13.Google Scholar
42. Chamoun, RB, Robertson, CS, Gopinath, SP. Outcome in patients with blunt head trauma and a Glasgow Coma Scale score of 3 at presentation. J Neurosurg. 2009;111(4):683-687.Google Scholar