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).

Laboratory study on the kinetics of the warming of cold fluids-A hot topic.

OBJECTIVES: In case of mild therapeutic hypothermia after an out-of-hospital cardiac arrest, several techniques could limit the cold fluid rewarming during its perfusion. We aimed to evaluate cold fluid temperature evolution and to identify the factors responsible for rewarming in order to suggest a prediction model of temperature evolution. EQUIPMENT AND METHODS: This was a laboratory experimental study. We measured temperature at the end of the infusion line tubes (ILT). A 500ml saline bag at 4°C was administered at 15 and 30ml/min, with and without cold packs applied to the cold fluid bag or to the ILT. Cold fluid temperature was integrated in a linear mixed model. Then we performed a mathematical modelization of the thermal transfer across the ILT. RESULTS: The linear mixed model showed that the mean temperature of the cold fluid was 1°C higher (CI 95%: [0.8-1.2]) with an outflow rate of 15 versus 30ml/min (P<0.001). Similarly, the mean temperature of the cold fluid was 0.7°C higher (CI 95%: [0.53-0.9]) without cold pack versus with cold packs (P<0.001). Mathematical modelization of the thermal transfer across the ILT suggested that the cold fluid warming could be reduced by a shorter and a wider ILT. As expected, use of CP has also a noticeable influence on warning reduction. The combination of multiple parameters working against the rewarming of the solution should enable the infusion of a solute with retained caloric properties. CONCLUSIONS: By limiting this "ILT effect," the volume required for inducing mild therapeutic hypothermia could be reduced, leading to a safer and a more efficient treatment.

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.