Prehospital Lyophilized Plasma Transfusion for Trauma-Induced Coagulopathy in Patients at Risk for Hemorrhagic Shock: A Randomized Clinical Trial.

Importance: Blood transfusion is a mainstay of therapy for trauma-induced coagulopathy, but the optimal modalities for plasma transfusion in the prehospital setting remain to be defined. Objective: To determine whether lyophilized plasma transfusion can reduce the incidence of trauma-induced coagulopathy compared with standard care consisting of normal saline infusion. Design, Setting, and Participants: This randomized clinical trial was performed at multiple centers in France involving prehospital medical teams. Participants included 150 adults with trauma who were at risk for hemorrhagic shock and associated coagulopathy between April 1, 2016, and September 30, 2019, with a 28-day follow-up. Data were analyzed from November 1, 2019, to July 1, 2020. Intervention: Patients were randomized in a 1:1 ratio to receive either plasma or standard care with normal saline infusion (control). Main Outcomes and Measures: The primary outcome was the international normalized ratio (INR) on arrival at the hospital. Secondary outcomes included the need for massive transfusion and 30-day survival. As a safety outcome, prespecified adverse events included thrombosis, transfusion-related acute lung injury, and transfusion-associated circulatory overload. Results: Among 150 randomized patients, 134 were included in the analysis (median age, 34 [IQR, 26-49] years; 110 men [82.1%]), with 68 in the plasma group and 66 in the control group. Median INR values were 1.21 (IQR, 1.12-1.49) in the plasma group and 1.20 (IQR, 1.10-1.39) in the control group (median difference, -0.01 [IQR, -0.09 to 0.08]; P = .88). The groups did not differ significantly in the need for massive transfusion (7 [10.3%] vs 4 [6.1%]; relative risk, 1.78 [95% CI, 0.42-8.68]; P = .37) or 30-day survival (hazard ratio for death, 1.07 [95% CI, 0.44-2.61]; P = .89). In the full intention-to-treat population (n = 150), the groups did not differ in the rates of any of the prespecified adverse events. Conclusions and Relevance: In this randomized clinical trial including severely injured patients at risk for hemorrhagic shock and associated coagulopathy, prehospital transfusion of lyophilized plasma was not associated with significant differences in INR values vs standard care with normal saline infusion. Nevertheless, these findings show that lyophilized plasma transfusion is a feasible and safe procedure for this patient population. Trial Registration: ClinicalTrials.gov Identifier: NCT02736812.

French lyophilized plasma versus normal saline for post-traumatic coagulopathy prevention and correction: PREHO-PLYO protocol for a multicenter randomized controlled clinical trial.

BACKGROUND: Post-trauma bleeding induces an acute deficiency in clotting factors, which promotes bleeding and hemorrhagic shock. However, early plasma administration may reduce the severity of trauma-induced coagulopathy (TIC). Unlike fresh frozen plasma, which requires specific hospital logistics, French lyophilized plasma (FLYP) is storable at room temperature and compatible with all blood types, supporting its use in prehospital emergency care. We aim to test the hypothesis that by attenuating TIC, FLYP administered by prehospital emergency physicians would benefit the severely injured civilian patient at risk for hemorrhagic shock. METHODS/DESIGN: This multicenter randomized clinical trial will include adults severely injured and at risk for hemorrhagic shock, with a systolic blood pressure < 70 mmHg or a Shock Index > 1.1. Two parallel groups of 70 patients will receive either FLYP or normal saline in addition to usual treatment. The primary endpoint is the International Normalized Ratio (INR) at hospital admission. Secondary endpoints are transfusion requirement, length of stay in the intensive care unit, survival rate at day 30, usability and safety related to FLYP use, and other biological coagulation parameters. CONCLUSION: With this trial, we aim to confirm the efficacy of FLYP in TIC and its safety in civilian prehospital care. The study results will contribute to optimizing guidelines for treating hemorrhagic shock in civilian settings. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02736812. Registered on 13 April 2016. The trial protocol has been approved by the French ethics committee (CPP 3342) and the French Agency for the Safety of Medicines and Health Products (IDRCB 2015-A00866-43).

Maternal out-of-hospital cardiac arrest: A retrospective observational study.

AIM: Out-of-hospital cardiac arrests (OHCAs) in pregnant women are rare events. In this study, we aimed to describe a cohort of pregnant women who experienced OHCAs in a large urban area, and received treatment by the prehospital teams in a two-tiered emergency response system. METHODS: This retrospective study included pregnant women over 18 years of age who experienced OHCAs. The analysed variables included maternal age, gestational age, variables specific to the rescue system, number of shocks delivered by an automatic external defibrillator, and rates of maternal and neonatal survival. RESULTS: Over the 5-year study period, 19,515 OHCAs occurred, 16 of which were in pregnant women. These 16 patients had a median age of 31 years [interquartile range (IQR): 28-35] and a median gestational age of 20 weeks [IQR: 10-33]. Three patients (18.8%) had an initial rhythm of ventricular fibrillation. Only one patient underwent thrombolysis. Of the 16 patients, 6 (38%) died after resuscitation on the scene. The remaining 10 were transported to the hospital, of whom 5 achieved circulation through a mechanical CPR device. Only 2 patients were alive 30days after OHCA. CONCLUSIONS: Over half of the pregnant women who experienced OHCA were at least 20 weeks pregnant. Analysis of the prehospital medical data suggests that the current recommendations are difficult to apply in an out-of-hospital environment. Specific recommendations for this situation must be developed.

Effect of continuous oxygen insufflation on induced-gastric air volume during cardiopulmonary resuscitation in a cadaveric model.

BACKGROUND: The main objective of this study was to compare the volume of gas insufflated in the stomach with continuous external chest compressions plus continuous oxygen insufflation (C-CPR) versus standard-CPR (S-CPR) which alternates external chest compressions and synchronized positive insufflations through a bag-valve-mask with a 30/2 ratio. The secondary objective was to compare upper airway pressures (intratracheal and intramask) generated during continuous oxygen insufflation. MATERIAL AND METHODS: Open, prospective, randomized, cross over, comparative, non-inferiority study. CPR was performed for six minutes periods, on seven fresh human corpses, with C-CPR or S-CPR in a random order. Before each CPR period, the stomach was completely emptied through the gastrostomy tube, and then 200 mL of air was injected in the stomach to be sure it was not collapsed. The gastric volume was measured at the end of each intervention. Intratracheal and intramask pressures were recorded continuously during C-CPR. Results were provided as mean ± standard deviation. Statistical analyses were done with a paired student t test. RESULTS: Induced-gastric inflation was lower with C-CPR (221 ± 130 mL) than with S-CPR (5401 ± 2208 mL, p = 0.001). Throughout C-CPR, no difference was found between the intratracheal and intramask pressures (4.4 ± 1.2; 4.0 ± 0.8 cmH2O, respectively, p = 0.45). CONCLUSION: This human cadaver study demonstrates that continuous oxygen insufflation induced less gastric inflation than intermittent insufflation during CPR.

[A spectacular revolution: evolution of French military health service]. / La révolution spectaculaire du Service de santé aux armées.

After the sanitary disaster caused by the first months of the conflict, the Health service of the French armies undertook a true revolution. By 1918, it had become the most efficient of all the opposing armies. At the end of 1914, through the spacing out of the evacuating hospitals within the zone of the armies, the most efficient teams were placed as close as possible to the front. Injured soldiers were categorized at every step of the chain. Technical progress, especially in war surgery, pushed medicine into the moderne era.