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Plasma-first resuscitation to treat haemorrhagic shock during emergency ground transportation in an urban area: A randomised trial

The Lancet Jul 30, 2018

Moore HB, et al. - The use of prehospital plasma during rapid ground rescue of patients with hemorrhagic shock before arrival at an urban level 1 trauma center was explored. Observations revealed no association of use of prehospital plasma with the survival benefit. In settings with longer transport times, blood products might be beneficial vs an urban environment with short distances to mature trauma centers where the financial burden would not be justified.

Methods

  • Researchers performed a pragmatic, randomized, single-center trial, the Control of Major Bleeding After Trauma Trial, at the Denver Health Medical Center (DHMC), which houses the paramedic division for Denver city.
  • They assessed consecutive trauma patients in hemorrhagic shock (defined as systolic blood pressure [SBP] ≤ 70 mm Hg or 71–90 mm Hg plus heart rate ≥ 108 beats per min) for eligibility at the scene of the injury by trained paramedics.
  • Plasma or normal saline (control) was administered to eligible patients randomly.
  • They achieved randomization via preloading all ambulances with sealed coolers at the start of each shift.
  • Based on a schedule generated by the research coordinators, they randomly assigned coolers to groups 1:1 in blocks of 20.
  • Mortality within 28 days of injury was assessed as the primary endpoint.
  • They performed analyses in the as-treated population and by intention to treat.

Results

  • Random assignment of 144 patients by paramedics to study groups was performed from April 1, 2014 to March 31, 2017.
  • One hundred and twenty-five eligible patients (median age: 33 years [IQR 25–47)] were included in the as-treated analysis, 65 received plasma and 60 received saline; median New Injury Severity Score was 27 (10–38).
  • Blood transfusions were performed in 70 (56%) patients within 6 hours of injury.
  • At baseline, the groups were noted to be similar; similar transport times were also reported for the groups (plasma group median 19 min [IQR 16–23] vs control 16 min [14–22]).
  • In terms of mortality at 28 days, no differences between the groups was noted (15% in the plasma group vs 10% in the control group, p=0.37).
  • In the intention-to-treat analysis, the groups displayed no significant differences in terms of safety outcomes and adverse events.
  • The study was stopped for futility after 144 of 150 planned enrolments due to the consistent lack of differences in the analyses.
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