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.

Insufficient quality of public automated external defibrillator recordings in the greater Paris area, a descriptive study.

BACKGROUND: Western countries report a significant increase in the proportion of patients who experience out-of-hospital cardiac arrests (OHCAs) and benefit from a public automated external defibrillator (pAED) before the arrival of rescue teams. However, recordings of devices recovered after resuscitation are of variable quality. Analysis of these data may inform decisions of whether to implement an internal defibrillator for survivors, and provide useful information about the performance of pAED algorithms and the actions of bystanders. OBJECTIVE: To investigate the quality of the information recorded by pAEDs during OHCAs in the Paris area. METHODS: pAED files used for some of the 8629 OHCAs that occurred in the greater Paris area between 1 January 2017 and 31 April 2019 on the day of the arrest were collected. The presence and accuracy of 23 factors required to interpret the recording was noted, including readability of the ECG, the presence of an impedance curve and the accuracy of the date and time. The recordings were analysed to assess the diagnostic and therapeutic performance of the pAEDs used. RESULTS: A total of 258 patients with an OHCA received assistance from a pAED, and 182 recordings were recovered. The pAEDs were made by 12 different manufacturers. Data extraction required eight different transmission modes and 16 software programmes; recordings were of highly heterogeneous quality. Two per cent of the recordings were of such poor quality that they were not interpretable. Among the 98% remaining, only 43% included a thoracic impedance curve, 34% the intensity of the shocks delivered and 8% the patient name. The date and time were accurate in 68% and 48% of recordings, respectively. The pAEDs had 87.6% (95% CI 83.7% to 91.0%) sensitivity and 99.5% (99.5% to 99.5%) specificity for defibrillating shockable rhythms (positive predictive value 98.2% (96.4% to 99.0%), negative predictive value 96.4% (95.3% to 96.8%)). The absence of important variables prevented the analysis of approximately half of the inappropriate decisions made by pAEDs. CONCLUSION: Collection of pAED recordings is a major challenge. Their analysis is compromised by heterogeneity and poor quality (incomplete maintenance records, patient details and logs). AED recordings are currently the most relevant resource to track pAED performance and bystander practices. The quality of these recordings needs to improve.

Contributing factors to early recurrence of ventricular fibrillation during out-of-hospital cardiac arrest: An observational retrospective study.

INTRODUCTION: In out-of-hospital cardiac arrest (OHCA), external electric shock (EES) is recommended for treating ventricular fibrillation (VF). Refibrillation commonly occurs within one minute post-shock. We aimed to investigate refibrillation times and identifyclinical and electrical factors associated with them. MATERIALS AND METHODS: This retrospective observational study, based on the Paris Fire Brigade database, included non-traumatic OHCA over 18 years of age who received at least one shock with an AED from Basic Life Support (BLS) rescuers and from which we randomly selected a sample to measure the refibrillation-times. Without prior reference to it in the literature, we classified the refibrillation-time into two modalities according to whether it was above or below the median-time. We performed multiple regression analysis to assess associations between refibrillation-time and potential explanatory factors. RESULTS: Among 13,181 patients who experienced OHCA from January 2010 to January 2014, we analysed AED data from 215 patients (590 shocks), 82.1% males, median age 61[IQR: 52-75] years. Most of them occurred at home (57%), were witnessed (87%), and were shockable (88.8%). A median of 5[4-7] EES/patients were delivered. The median-time from shock to refibrillation was 25[13-44] s. Multivariate analysis showed that a shorter post-shock hands-off time favoured earlier refibrillation (p = 0.034), as well as older age (p = 0.002) (Fig. 2, Supplementary table). CONCLUSION: In non-traumatic OHCA, most refibrillations occurred within 45-s post-shock. Age and post-shock hands-off time were the two contributing factors to time to refibrillation.

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).

[Medication reconciliation: an innovative experience in an internal medicine unit to decrease errors due to inacurrate medication histories]. / Conciliation médicamenteuse : une expérience innovante dans un service de médecine interne pour diminuer les erreurs d'anamnèse médicamenteuses.

PURPOSE: An inaccurate medication history may prevent the discovery of a pre-admission iatrogenic event or lead to interrupted drug therapy during hospitalization. Medication reconciliation is a process that ensures the transfer of medication information at admission to the hospital. The aims of this prospective study were to evaluate the interest in clinical practice of this concept and the resources needed for its implementation. METHODS: We chose to include patients aged 65 years or over admitted in the internal medicine unit between June and October 2010. We obtained an accurate list of each patient's home medications. This list was then compared with medication orders. All medication variances were classified as intended or unintended. An internist and a pharmacist classified the clinical importance of each unintended variance. RESULTS: Sixty-one patients (mean age: 78 ± 7.4 years) were included in our study. We identified 38 unintended discrepancies. The average number of unintended discrepancies was 0.62 per patient. Twenty-five patients (41%) had one or more unintended discrepancies at admission. The contact with the community pharmacist permitted us to identify 21 (55%) unintended discrepancies. The most common errors were the omission of a regularly used medication (76%) and an incorrect dosage (16%). Our intervention resulted in order changes by the physician for 30 (79%) unintended discrepancies. Fifty percent of the unintended variances were judged by the internist and 76% by the pharmacist to be clinically significant. CONCLUSION: The admission to the hospital is a critical transition point for the continuity of care in medication management. Medication reconciliation can identify and resolve errors due to inaccurate medication histories.

Improvement in diagnosis of rheumatoid arthritis using dual indirect immunofluorescence and immunoblotting assays for antifilaggrin autoantibodies: a retrospective 3 year study.

OBJECTIVE: To determine the clinical usefulness of measuring antistratum corneum (ASC) and antifilaggrin autoantibodies (AFA) to discriminate between rheumatoid arthritis (RA) and other rheumatic or autoimmune diseases, using an indirect immunofluorescence (IIF) assay, along with a complementary immunoblotting technique (IB) when IIF detection of ASC was negative. METHODS: Sera from 346 patients were studied: 189 sera from patients with RA seen in the same clinic, 92 from patients with non-RA rheumatic diseases, 24 from nonrheumatic autoimmune diseases, and 41 from healthy blood donors. ASC and AFA were detected using IIF and IB, respectively. RESULTS: ASC detection using IIF showed a specificity of 97.5% for RA with 44.4% sensitivity. When both IIF and IB techniques were used, sensitivity for RA increased significantly (up to 53.4%; p < 0.01) with no decrease in specificity (p < 0.01). CONCLUSION: These data confirm the usefulness of 2 different techniques performed simultaneously for detecting ASC/AFA, and the usefulness of these biological markers for discriminating between RA and other rheumatic diseases in clinical practice.