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Randomized Controlled Trial
. 2020 Oct 1;3(10):e2016869.
doi: 10.1001/jamanetworkopen.2020.16869.

Association of Prehospital Plasma With Survival in Patients With Traumatic Brain Injury: A Secondary Analysis of the PAMPer Cluster Randomized Clinical Trial

Danielle S Gruen  1   2 , Francis X Guyette  3 , Joshua B Brown  1   2 , David O Okonkwo  4 , Ava M Puccio  4 , Insiyah K Campwala  1   2 , Matthew T Tessmer  1   2 , Brian J Daley  5 , Richard S Miller  6 , Brian G Harbrecht  7 , Jeffrey A Claridge  8 , Herb A Phelan  9 , Matthew D Neal  1   2 , Brian S Zuckerbraun  1   2 , Mark H Yazer  10 , Timothy R Billiar  1   2 , Jason L Sperry  1   2
Affiliations
Randomized Controlled Trial

Association of Prehospital Plasma With Survival in Patients With Traumatic Brain Injury: A Secondary Analysis of the PAMPer Cluster Randomized Clinical Trial

Danielle S Gruen et al. JAMA Netw Open. .

Abstract

Importance: Prehospital plasma administration improves survival in injured patients at risk for hemorrhagic shock and transported by air ambulance. Traumatic brain injury (TBI) is a leading cause of death following trauma, but few early interventions improve outcomes.

Objective: To assess the association between prehospital plasma and survival in patients with TBI.

Design, setting, and participants: The Prehospital Air Medical Plasma (PAMPer) trial was a pragmatic, multicenter, phase 3, cluster randomized clinical trial involving injured patients who were at risk for hemorrhagic shock during air medical transport to a trauma center. The trial was conducted at 6 US sites with 9 level-I trauma centers (comprising 27 helicopter emergency services bases). The original trial analyzed 501 patients, including 230 patients who were randomized to receive plasma and 271 randomized to standard care resuscitation. This secondary analysis of a predefined subgroup included patients with TBI. Data analysis was performed from October 2019 to February 2020.

Interventions: Patients were randomized to receive standard care fluid resuscitation or 2 units of thawed plasma.

Main outcomes and measures: The primary outcome was mortality at 30 days. Patients with TBI were prespecified as a subgroup for secondary analysis and for measurement of markers of brain injury. The 30-day survival benefit of prehospital plasma in subgroups with and without TBI as diagnosed by computed tomography was characterized using Kaplan-Meier survival analysis and Cox proportional hazard regression.

Results: In total, 166 patients had TBI (median [interquartile range] age, 43.00 [25.00-59.75] years; 125 men [75.3%]). When compared with the 92 patients who received standard care, the 74 patients with TBI who received prehospital plasma had improved 30-day survival even after adjustment for multiple confounders and assessment of the degree of brain injury with clinical variables and biomarkers (hazard ratio [HR], 0.55; 95% CI, 0.33-0.94; P = .03). Receipt of prehospital plasma was associated with improved survival among patients with TBI with a prehospital Glasgow Coma Scale score of less than 8 (HR, 0.56; 95% CI, 0.35-0.91) and those with polytrauma (HR, 0.50; 95% CI, 0.28-0.89). Patients with TBI transported from the scene of injury had improved survival following prehospital plasma administration (HR, 0.45; 95% CI, 0.26-0.80; P = .005), whereas patients who were transferred from an outside hospital showed no difference in survival for the plasma intervention (HR, 1.00; 95% CI, 0.33-3.00; P = .99).

Conclusions and relevance: These findings are exploratory, but they suggest that receipt of prehospital plasma is associated with improved survival in patients with computed tomography-positive TBI. The prehospital setting may be a critical period to intervene in the care of patients with TBI. Future studies are needed to confirm the clinical benefits of early plasma resuscitation following TBI and concomitant polytrauma.

Trial registration: ClinicalTrials.gov Identifier: NCT01818427.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Gruen reported receiving grants from the National Institutes of Health (NIH) and the Department of Defense during the conduct of the study. Dr Harbrecht reported receiving grants from Instrument Laboratories and Noveome; grants, personal fees, and nonfinancial support from Haemonetics; grants and personal fees from Janssen Pharmaceuticals; nonfinancial support from Haima Therapeutics; and personal fees from CSL Behring outside the submitted work. Dr Neal reported receiving grants from NIH, Instrumentation Laboratories, and Noveome during the conduct of the study; grants and personal fees from Janssen Pharmaceuticals and Haemonetics; nonfinancial support from Haima Therapeutics; and personal fees from CSL Behring outside the submitted work. Dr Yazer reported receiving personal fees from Grifols, Terumo, Haemonetics, New Heath Sciences, Macopharma, Octapharma, Cerus, Verax, Aktivax, and Cook Biomedical outside the submitted work. Dr Billiar reported receiving grants from NIH during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Patient Selection Flowchart
TBI indicates traumatic brain injury.
Figure 2.
Figure 2.. Unadjusted Kaplan-Meier Survival Analysis for 30-Day Survival Comparing Prehospital Plasma and Standard Care Patients With and Without Traumatic Brain Injury
P values were calculated with log-rank testing.
Figure 3.
Figure 3.. Hazard Ratios (HRs) for Each Subgroup Derived From a Cox Proportional Hazard Model
HRs are reported for prehospital plasma compared with standard care. HRs less than or equal to 1 indicate a decreased risk of death; HRs greater than 1 indicate an increased risk of death. Traumatic brain injury (TBI) with mild to moderate traumatic injury in other body regions is defined by the presence of TBI and Abbreviated Injury Severity (AIS) score less than 3 in nonhead AIS categories (abdomen, chest, and extremity). Polytrauma with TBI is defined by the presence of TBI and AIS score of 3 or higher in the abdomen, chest, or extremity categories. GCS indicates Glasgow Coma Scale.
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