Prehospital plasma during air medical transport in trauma patients at risk for hemorrhagic shock

Jason L. Sperry, Francis X. Guyette, Joshua B. Brown, Mark H. Yazer, Darrell J. Triulzi, Barbara J. Early-Young, Peter W. Adams, Brian J. Daley, Richard S. Miller, Brian G. Harbrecht, Jeffrey A. Claridge, Herb A. Phelan, William R. Witham, A. Tyler Putnam, Therese M. Duane, Louis H. Alarcon, Clifton W. Callaway, Brian S. Zuckerbraun, Matthew D. Neal, Matthew R. RosengartRaquel M. Forsythe, Timothy R. Billiar, Donald M. Yealy, Andrew B. Peitzman, Mazen S. Zenati

Research output: Contribution to journalArticle

72 Citations (Scopus)

Abstract

BACKGROUND After a person has been injured, prehospital administration of plasma in addition to the initiation of standard resuscitation procedures in the prehospital environment may reduce the risk of downstream complications from hemorrhage and shock. Data from large clinical trials are lacking to show either the efficacy or the risks associated with plasma transfusion in the prehospital setting. METHODS To determine the efficacy and safety of prehospital administration of thawed plasma in injured patients who are at risk for hemorrhagic shock, we conducted a pragmatic, multicenter, cluster-randomized, phase 3 superiority trial that compared the administration of thawed plasma with standard-care resuscitation during air medical transport. The primary outcome was mortality at 30 days. RESULTS A total of 501 patients were evaluated: 230 patients received plasma (plasma group) and 271 received standard-care resuscitation (standard-care group). Mortality at 30 days was significantly lower in the plasma group than in the standard-care group (23.2% vs. 33.0%; difference, −9.8 percentage points; 95% confidence interval, −18.6 to −1.0%; P=0.03). A similar treatment effect was observed across nine prespecified subgroups (heterogeneity chi-square test, 12.21; P=0.79). Kaplan-Meier curves showed an early separation of the two treatment groups that began 3 hours after randomization and persisted until 30 days after randomization (log-rank chi-square test, 5.70; P=0.02). The median prothrombin-time ratio was lower in the plasma group than in the standard-care group (1.2 [interquartile range, 1.1 to 1.4] vs. 1.3 [interquartile range, 1.1 to 1.6], P<0.001) after the patients' arrival at the trauma center. No significant differences between the two groups were noted with respect to multiorgan failure, acute lung injury-acute respiratory distress syndrome, nosocomial infections, or allergic or transfusion-related reactions. CONCLUSIONS In injured patients at risk for hemorrhagic shock, the prehospital administration of thawed plasma was safe and resulted in lower 30-day mortality and a lower median prothrombin-time ratio than standard-care resuscitation. (Funded by the U.S. Army Medical Research and Materiel Command; PAMPer ClinicalTrials.gov number, NCT01818427).

Original languageEnglish (US)
Pages (from-to)315-326
Number of pages12
JournalNew England Journal of Medicine
Volume379
Issue number4
DOIs
StatePublished - Jul 26 2018

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Hemorrhagic Shock
Air
Wounds and Injuries
Resuscitation
Prothrombin Time
Chi-Square Distribution
Random Allocation
Mortality
Acute Lung Injury
Trauma Centers
Adult Respiratory Distress Syndrome
Standard of Care
Cross Infection
Biomedical Research
Shock
Clinical Trials
Confidence Intervals
Hemorrhage
Safety
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Sperry, J. L., Guyette, F. X., Brown, J. B., Yazer, M. H., Triulzi, D. J., Early-Young, B. J., ... Zenati, M. S. (2018). Prehospital plasma during air medical transport in trauma patients at risk for hemorrhagic shock. New England Journal of Medicine, 379(4), 315-326. https://doi.org/10.1056/NEJMoa1802345

Prehospital plasma during air medical transport in trauma patients at risk for hemorrhagic shock. / Sperry, Jason L.; Guyette, Francis X.; Brown, Joshua B.; Yazer, Mark H.; Triulzi, Darrell J.; Early-Young, Barbara J.; Adams, Peter W.; Daley, Brian J.; Miller, Richard S.; Harbrecht, Brian G.; Claridge, Jeffrey A.; Phelan, Herb A.; Witham, William R.; Tyler Putnam, A.; Duane, Therese M.; Alarcon, Louis H.; Callaway, Clifton W.; Zuckerbraun, Brian S.; Neal, Matthew D.; Rosengart, Matthew R.; Forsythe, Raquel M.; Billiar, Timothy R.; Yealy, Donald M.; Peitzman, Andrew B.; Zenati, Mazen S.

In: New England Journal of Medicine, Vol. 379, No. 4, 26.07.2018, p. 315-326.

Research output: Contribution to journalArticle

Sperry, JL, Guyette, FX, Brown, JB, Yazer, MH, Triulzi, DJ, Early-Young, BJ, Adams, PW, Daley, BJ, Miller, RS, Harbrecht, BG, Claridge, JA, Phelan, HA, Witham, WR, Tyler Putnam, A, Duane, TM, Alarcon, LH, Callaway, CW, Zuckerbraun, BS, Neal, MD, Rosengart, MR, Forsythe, RM, Billiar, TR, Yealy, DM, Peitzman, AB & Zenati, MS 2018, 'Prehospital plasma during air medical transport in trauma patients at risk for hemorrhagic shock', New England Journal of Medicine, vol. 379, no. 4, pp. 315-326. https://doi.org/10.1056/NEJMoa1802345
Sperry, Jason L. ; Guyette, Francis X. ; Brown, Joshua B. ; Yazer, Mark H. ; Triulzi, Darrell J. ; Early-Young, Barbara J. ; Adams, Peter W. ; Daley, Brian J. ; Miller, Richard S. ; Harbrecht, Brian G. ; Claridge, Jeffrey A. ; Phelan, Herb A. ; Witham, William R. ; Tyler Putnam, A. ; Duane, Therese M. ; Alarcon, Louis H. ; Callaway, Clifton W. ; Zuckerbraun, Brian S. ; Neal, Matthew D. ; Rosengart, Matthew R. ; Forsythe, Raquel M. ; Billiar, Timothy R. ; Yealy, Donald M. ; Peitzman, Andrew B. ; Zenati, Mazen S. / Prehospital plasma during air medical transport in trauma patients at risk for hemorrhagic shock. In: New England Journal of Medicine. 2018 ; Vol. 379, No. 4. pp. 315-326.
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TY - JOUR

T1 - Prehospital plasma during air medical transport in trauma patients at risk for hemorrhagic shock

AU - Sperry, Jason L.

AU - Guyette, Francis X.

AU - Brown, Joshua B.

AU - Yazer, Mark H.

AU - Triulzi, Darrell J.

AU - Early-Young, Barbara J.

AU - Adams, Peter W.

AU - Daley, Brian J.

AU - Miller, Richard S.

AU - Harbrecht, Brian G.

AU - Claridge, Jeffrey A.

AU - Phelan, Herb A.

AU - Witham, William R.

AU - Tyler Putnam, A.

AU - Duane, Therese M.

AU - Alarcon, Louis H.

AU - Callaway, Clifton W.

AU - Zuckerbraun, Brian S.

AU - Neal, Matthew D.

AU - Rosengart, Matthew R.

AU - Forsythe, Raquel M.

AU - Billiar, Timothy R.

AU - Yealy, Donald M.

AU - Peitzman, Andrew B.

AU - Zenati, Mazen S.

PY - 2018/7/26

Y1 - 2018/7/26

N2 - BACKGROUND After a person has been injured, prehospital administration of plasma in addition to the initiation of standard resuscitation procedures in the prehospital environment may reduce the risk of downstream complications from hemorrhage and shock. Data from large clinical trials are lacking to show either the efficacy or the risks associated with plasma transfusion in the prehospital setting. METHODS To determine the efficacy and safety of prehospital administration of thawed plasma in injured patients who are at risk for hemorrhagic shock, we conducted a pragmatic, multicenter, cluster-randomized, phase 3 superiority trial that compared the administration of thawed plasma with standard-care resuscitation during air medical transport. The primary outcome was mortality at 30 days. RESULTS A total of 501 patients were evaluated: 230 patients received plasma (plasma group) and 271 received standard-care resuscitation (standard-care group). Mortality at 30 days was significantly lower in the plasma group than in the standard-care group (23.2% vs. 33.0%; difference, −9.8 percentage points; 95% confidence interval, −18.6 to −1.0%; P=0.03). A similar treatment effect was observed across nine prespecified subgroups (heterogeneity chi-square test, 12.21; P=0.79). Kaplan-Meier curves showed an early separation of the two treatment groups that began 3 hours after randomization and persisted until 30 days after randomization (log-rank chi-square test, 5.70; P=0.02). The median prothrombin-time ratio was lower in the plasma group than in the standard-care group (1.2 [interquartile range, 1.1 to 1.4] vs. 1.3 [interquartile range, 1.1 to 1.6], P<0.001) after the patients' arrival at the trauma center. No significant differences between the two groups were noted with respect to multiorgan failure, acute lung injury-acute respiratory distress syndrome, nosocomial infections, or allergic or transfusion-related reactions. CONCLUSIONS In injured patients at risk for hemorrhagic shock, the prehospital administration of thawed plasma was safe and resulted in lower 30-day mortality and a lower median prothrombin-time ratio than standard-care resuscitation. (Funded by the U.S. Army Medical Research and Materiel Command; PAMPer ClinicalTrials.gov number, NCT01818427).

AB - BACKGROUND After a person has been injured, prehospital administration of plasma in addition to the initiation of standard resuscitation procedures in the prehospital environment may reduce the risk of downstream complications from hemorrhage and shock. Data from large clinical trials are lacking to show either the efficacy or the risks associated with plasma transfusion in the prehospital setting. METHODS To determine the efficacy and safety of prehospital administration of thawed plasma in injured patients who are at risk for hemorrhagic shock, we conducted a pragmatic, multicenter, cluster-randomized, phase 3 superiority trial that compared the administration of thawed plasma with standard-care resuscitation during air medical transport. The primary outcome was mortality at 30 days. RESULTS A total of 501 patients were evaluated: 230 patients received plasma (plasma group) and 271 received standard-care resuscitation (standard-care group). Mortality at 30 days was significantly lower in the plasma group than in the standard-care group (23.2% vs. 33.0%; difference, −9.8 percentage points; 95% confidence interval, −18.6 to −1.0%; P=0.03). A similar treatment effect was observed across nine prespecified subgroups (heterogeneity chi-square test, 12.21; P=0.79). Kaplan-Meier curves showed an early separation of the two treatment groups that began 3 hours after randomization and persisted until 30 days after randomization (log-rank chi-square test, 5.70; P=0.02). The median prothrombin-time ratio was lower in the plasma group than in the standard-care group (1.2 [interquartile range, 1.1 to 1.4] vs. 1.3 [interquartile range, 1.1 to 1.6], P<0.001) after the patients' arrival at the trauma center. No significant differences between the two groups were noted with respect to multiorgan failure, acute lung injury-acute respiratory distress syndrome, nosocomial infections, or allergic or transfusion-related reactions. CONCLUSIONS In injured patients at risk for hemorrhagic shock, the prehospital administration of thawed plasma was safe and resulted in lower 30-day mortality and a lower median prothrombin-time ratio than standard-care resuscitation. (Funded by the U.S. Army Medical Research and Materiel Command; PAMPer ClinicalTrials.gov number, NCT01818427).

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