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).

A New Triage Support Tool in Case of Explosion.

Deafness frequently observed in explosion victims, currently following terrorist attack, is a barrier to communication between victims and first responders. This may result in a delay in the initial triage and evacuation. In such situations, Paris Fire Brigade (Paris, France) proposes the use of assistance cards to help conscious, but deafened patients at the site of an attack where there may be numerous victims. Yavari-Sartakhti O , Briche F , Jost D , Michaud N , Bignand M , Tourtier JP . A new triage support tool in case of explosion. Prehosp Disaster Med. 2018;33(2):213-214.

Usefulness of a multiplying factor in predicting the final number of victims during a mass casualty incident.

OBJECTIVE: Whenever a mass casualty incident (MCI) occurs, it is essential to anticipate the final number of victims to dispatch the adequate number of ambulances. In France, the custom is to multiply the initial number of prehospital victims by 2-4 to predict the final number. However, no one has yet validated this multiplying factor (MF) as a predictive tool. We aimed to build a statistical model to predict the final number of victims from their initial count. METHODS: We observed retrospectively over 30 years of MCIs triggered in a large urban area. We considered three types of events: explosions, fires, and road traffic accidents. We collected the initial and final numbers of victims, with distinction between deaths, critical victims (T1), and delayed or minimal victims (T2-T3). The MF was calculated for each category of victims according to each type of event. Using a Poisson multivariate regression, we calculated the incidence risk ratio (IRR) of the final number of T1 as a function of the initial deaths and the initial T2-T3 counts, while controlling for potential confounding variables. RESULTS: Sixty-eight MCIs were included. The final number of T1 increased with the initial incidence of deaths [IRR: 1.8 (1.4-2.2)], the initial number of T2-T3 being greater than 12 [IRR: 1.6 (1.3-2.1)], and the presence of one or more explosion [IRR: 1.4 (1.1-1.8)]. CONCLUSION: The MF seems to be an appealing decision-making tool to anticipate the need for ambulance resources. In explosive MCIs, we recommend multiplying T1 by 1.4 to estimate final count and the need for supplementary advanced life support teams.

Hands-off Time during Automated Chest Compression Device Application in Out-of-Hospital Cardiac Arrest: A Case Series Report.

INTRODUCTION: During out-of-hospital cardiac arrest (OHCA), chest compression interruptions or hands-off time (HOT) affect the prognosis. Our aim was to measure HOT due to the application of an automated chest compression device (ACD) by an advanced life support team. MATERIALS AND METHODS: This was a prospective observational case series report since the introduction of a new method of installing the ACD. Inclusion criteria were patients over 18 years old with OHCA who were treated with an ACD (Lucas 2(TM), Physio-Control). The ACD application was indicated only for OHCA patients transported to a hospital for Extra Corporeal Life Support (ECLS). We recorded the HOT related to switching from manual to mechanical chest compressions. An ACD consists of dorsal and ventral components, which can be installed either in one or in two steps, separated from a chest compression sequence. HOT was expressed as a median number of seconds [interquartile range]. RESULTS: From January 1, 2012 to January 15, 2013, 30 patients were included. In the case of ACD application in one phase (n = 16), the median HOT was 25.3 s [19.8-30.5]. With regard to patients with an ACD application in two phases (n = 14), the median HOT was, respectively, 9.8 s [7.8-17] and 12.4 s [9.5-16.2], that is, a median global HOT of 23.6 s [19-27.6]. HOT was not different between ACD applications in one or two phases (p = 0.52). For a two phase application, the median chest compression time between the two manipulations was 14.2 s [6.4-18]. CONCLUSION: There was no significant difference between techniques in the application of the Lucas 2(TM) device in terms of HOT. The short time needed to apply the device lends itself well to use as a primary chest compression modality during cardiac arrest as well as a bridge to novel resuscitation strategies (ECLS). A further study is currently underway with a larger number of ECLS patients.

Hemostatic dressings in civil prehospital practice: 30 uses of QuikClot Combat Gauze.

To report the use and describe the interest of hemostatic dressings in a civilian setting, we provided medical prehospital teams with QuikClot Combat Gauze (QCG) and asked physicians to complete a specific questionnaire after each use. Thirty uses were prospectively reported. The wounds were mostly caused by cold steel (n=15) and were primarily cervicocephalic (n=16), with 19/30 active arterial bleedings. For 26/30 uses, hemostatic dressing was justified by the inefficiency of other hemostasis techniques. Those 30 applications were associated with 22 complete cessations of bleeding, six decreases of bleeding, and ineffectiveness in two cases. The application of QCG permitted the removal of an effective tourniquet that was applied initially for three patients. No side-effects were reported. The provision of hemostatic dressings in civilian resuscitation ambulances was useful by providing an additional tool to limit bleeding while rapidly transporting the injured patient to a surgical facility.