Patient-Specific Precision Injury Signatures to Optimize Orthopaedic Interventions in Multiply Injured Patients (PRECISE STUDY).
Journal
Journal of orthopaedic trauma
ISSN: 1531-2291
Titre abrégé: J Orthop Trauma
Pays: United States
ID NLM: 8807705
Informations de publication
Date de publication:
01 Jan 2022
01 Jan 2022
Historique:
accepted:
08
10
2021
entrez:
20
12
2021
pubmed:
21
12
2021
medline:
28
1
2022
Statut:
ppublish
Résumé
Optimal timing and procedure selection that define staged treatment strategies can affect outcomes dramatically and remain an area of major debate in the treatment of multiply injured orthopaedic trauma patients. Decisions regarding timing and choice of orthopaedic procedure(s) are currently based on the physiologic condition of the patient, resource availability, and the expected magnitude of the intervention. Surgical decision-making algorithms rarely rely on precision-type data that account for demographics, magnitude of injury, and the physiologic/immunologic response to injury on a patient-specific basis. This study is a multicenter prospective investigation that will work toward developing a precision medicine approach to managing multiply injured patients by incorporating patient-specific indices that quantify (1) mechanical tissue damage volume; (2) cumulative hypoperfusion; (3) immunologic response; and (4) demographics. These indices will formulate a precision injury signature, unique to each patient, which will be explored for correspondence to outcomes and response to surgical interventions. The impact of the timing and magnitude of initial and staged surgical interventions on patient-specific physiologic and immunologic responses will be evaluated and described. The primary goal of the study will be the development of data-driven models that will inform clinical decision-making tools that can be used to predict outcomes and guide intervention decisions.
Identifiants
pubmed: 34924514
doi: 10.1097/BOT.0000000000002289
pii: 00005131-202201001-00004
doi:
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
S14-S20Informations de copyright
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Références
Belmont PJ Jr, McCriskin BJ, Hsiao MS, et al. The nature and incidence of musculoskeletal combat wounds in Iraq and Afghanistan (2005–2009). J Orthop Trauma. 2013;27:e107–113.
Schoenfeld AJ, Dunn JC, Bader JO, et al. The nature and extent of war injuries sustained by combat specialty personnel killed and wounded in Afghanistan and Iraq, 2003-2011. J Trauma Acute Care Surg. 2013;75:287–291.
Pape HC, Giannoudis PV, Krettek C, et al. Timing of fixation of major fractures in blunt polytrauma: role of conventional indicators in clinical decision making. J Orthop Trauma. 2005;19:551–562.
Vallier HA, Wang X, Moore TA, et al. Timing of orthopaedic surgery in multiple trauma patients: development of a protocol for early appropriate care. J Orthop Trauma. 2013;27:543–551.
Steinhausen E, Lefering R, Tjardes T, et al. A risk-adapted approach is beneficial in the management of bilateral femoral shaft fractures in multiple trauma patients: an analysis based on the trauma registry of the German trauma society. J Trauma Acute Care Surg. 2014;76:1288–1293.
Balazs GC, Blais MB, Bluman EM, et al. Blurred front lines: triage and initial management of blast injuries. Curr Rev Musculoskelet Med. 2015;8:304–311.
Covey DC. Combat orthopaedics: a view from the trenches. J Am Acad Orthop Surg. 2006;14(10 Spec No.):S10–S17.
Scalea TM, Boswell SA, Scott JD, et al. External fixation as a bridge to intramedullary nailing for patients with multiple injuries and with femur fractures: damage control orthopedics. J Trauma. 2000;48:613–621; discussion 621-623.
Flierl MA, Stoneback JW, Beauchamp KM, et al. Femur shaft fracture fixation in head-injured patients: when is the right time? J Orthop Trauma. 2010;24:107–114.
O'Toole RV, O'Brien M, Scalea TM, et al. Resuscitation before stabilization of femoral fractures limits acute respiratory distress syndrome in patients with multiple traumatic injuries despite low use of damage control orthopedics. J Trauma. 2009;67:1013–1021.
Pape HC, Rixen D, Morley J, et al. Impact of the method of initial stabilization for femoral shaft fractures in patients with multiple injuries at risk for complications (borderline patients). Ann Surg. 2007;246:491–499; discussion 499-501.
Buchman TG, Billiar TR, Elster E, et al. Precision medicine for critical illness and injury. Crit Care Med. 2016;44:1635–1638.
Kassab GS, An G, Sander EA, et al. Augmenting surgery via multi-scale modeling and translational systems biology in the era of precision medicine: a multidisciplinary perspective. Ann Biomed Eng. 2016;44:2611–2625.
Frantz TL, Steenburg SD, Gaski GE, et al. Tissue damage volume predicts organ dysfunction and inflammation after injury. J Surg Res. 2016;202:188–195.
Gaski G, Frantz T, Steenburg S, et al. Large-magnitude pelvic and retroperitoneal tissue damage predicts organ failure. Clin Orthop Relat Res. 2016;474:1410–1416.
McKinley TO, McCarroll T, Gaski GE, et al. Shock volume: a patient-specific index that predicts transfusion requirements and organ dysfunction in multiply injured patients. Shock. 2016;45:126–132.
McKinley TO, McCarroll T, Metzger C, et al. Shock volume: patient-specific cumulative hypoperfusion predicts organ dysfunction in a prospective cohort of multiply injured patients. J Trauma Acute Care Surg. 2018;85:S84–S91.
Almahmoud K, Namas RA, Abdul-Malak O, et al. Impact of injury severity on dynamic inflammation networks following blunt trauma. Shock. 2015;44:101–109.
Billiar TR, Vodovotz Y. Time for trauma immunology. PLoS Med. 2017;14:e1002342.
Namas RA, Vodovotz Y, Almahmoud K, et al. Temporal patterns of circulating inflammation biomarker networks differentiate susceptibility to nosocomial infection following blunt trauma in humans. Ann Surg. 2016;263:191–198.
Namas RA, Almahmoud K, Mi Q, et al. Individual-specific principal component analysis of circulating inflammatory mediators predicts early organ dysfunction in trauma patients. J Crit Care. 2016;36:146–153.
Schimunek L, Lindberg H, Cohen M, et al. Computational derivation of core, dynamic human blunt trauma inflammatory endotypes. Front Immunol. 2021;11:589304.
Almahmoud K, Abboud A, Namas RA, et al. Computational evidence for an early, amplified systemic inflammation program in polytrauma patients with severe extremity injuries. PLoS One. 2019;14:e0217577.
McKinley TO, Gaski GE, Zamora R, et al. Early dynamic orchestration of immunologic mediators identifies multiply injured patients who are tolerant or sensitive to hemorrhage. J Trauma Acute Care Surg. 2021;90:441–450.
Fox EE, Holcomb JB, Wade CE, et al. Earlier endpoints are required for hemorrhagic shock trials among severely injured patients. Shock. 2017;47:567–573.
Marshall JC, Cook DJ, Christou NV, et al. Multiple organ dysfunction score: a reliable descriptor of a complex clinical outcome. Crit Care Med. 1995;23:1638–1652.
Gaski GE, Metzger C, McCarroll T, et al. Early immunologic response in multiply injured patients with orthopaedic injuries is associated with organ dysfunction. J Orthop Trauma. 2019;33:220–228.
Centers for Disease Control and Prevention; National Healthcare Safety Network. Bloodstream Infection Event (Central Line-Associated Bloodstream Infection and Non-central Line Associated Bloodstream Infection) [NHSN Patient Safety Component Manual]. 2019. Available at: https://www.cdc.gov/nhsn/pdfs/pscmanual/4psc_clabscurrent.pdf . Accessed 2019.
Centers for Disease Control and Prevention; National Healthcare Safety Network. Pneumonia (Ventilator-associated [VAP] and Non-ventilator-associated Pneumonia [PNEU]) Event [NHSN Patient Safety Component Manual]. 2019. Available at: https://www.cdc.gov/nhsn/pdfs/pscmanual/6pscvapcurrent.pdf . Accessed 2019.
Centers for Disease Control and Prevention; National Healthcare Safety Network. Urinary Tract Infection (Catheter-associated Urinary Tract Infection [CAUTI] and Non-catheter-associated Urinary Tract Infection [UTI]) Events [NHSN Patient Safety Component Manual]. 2019. Available at: https://www.cdc.gov/nhsn/pdfs/pscmanual/7psccauticurrent.pdf . Accessed 2019.
Centers for Disease Control and Prevention; National Healthcare Safety Network. Surgical site infection event (SSI). In: [NHSN Patient Safety Component Manual]. 2019. Available at: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf . Accessed 2019.
American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005;171:388–416.
Al-Mekhlafi A, Becker T, Klawonn F. Sample size and performance estimation for biomarker combinations based on pilot studies with small sample sizes. Commun Stat Theor Methods. 2020;49:1–15.
Lai D, King TM, Moyé LA, et al. Sample size for biomarker studies: more subjects or more measurements per subject? Ann Epidemiol. 2003;13:204–208.
Wallstrom G, Anderson KS, LaBaer J. Biomarker discovery for heterogeneous diseases. Cancer Epidemiol Biomarkers Prev. 2013;22:747–755.
McKeigue P. Sample size requirements for learning to classify with high-dimensional biomarker panels. Stat Methods Med Res. 2019;28:904–910.
Namas RA, Mi Q, Namas R, et al. Insights into the role of chemokines, damage-associated molecular patterns, and lymphocyte-derived mediators from computational models of trauma-induced inflammation. Antioxid Redox Signal. 2015;23:1370–1387.
Bonaroti J, Abdelhamid S, Kar U, et al. The use of multiplexing to identify cytokine and chemokine networks in the immune-inflammatory response to trauma [published online ahead of print, 2021 May 19]. Antioxid Redox Signal. 2021. doi:10.1089/ars.2021.0054.
doi: 10.1089/ars.2021.0054
Alemi F, Erdman H, Griva I, et al. Improved statistical methods are needed to advance personalized medicine. Open Transl Med J. 2009;1:16–20.
Bottomly D, Ryabinin PA, Tyner JW, et al. Comparison of methods to identify aberrant expression patterns in individual patients: augmenting our toolkit for precision medicine. Genome Med. 2013;5:103.
Gaile DP, Miecznikowski JC. From small studies to precision medicine: prioritizing candidate biomarkers. Genome Med. 2013;5:104.
Kotwal RS, Howard JT, Orman JA, et al. The effect of a golden hour policy on the morbidity and mortality of combat casualties. JAMA Surg. 2016;151:15–24.
Holcomb JB, Tilley BC, Baraniuk S, et al. 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. 2015;313:471–482.
Vanzant EL, Lopez CM, Ozrazgat-Baslanti T, et al. Persistent inflammation, immunosuppression, and catabolism syndrome after severe blunt trauma. J Trauma Acute Care Surg. 2014;76:21–29; discussion 29-30.
National Institutes of Health. Precision Medicine Initiative. 2015. Available at: https://www.nih.gov/sites/default/files/research-training/initiatives/pmi/pmi-working-group-report-20150917-2.pdf . Accessed August 15, 2021.