Efficacy and tolerance of early administration of tranexamic acid in patients with cirrhosis presenting with acute upper gastrointestinal bleeding: a study protocol for a multicentre, randomised, double-blind, placebo-controlled trial (the EXARHOSE study).

INTRODUCTION: The management of acute upper gastrointestinal bleeding (UGIB) is challenging in patients with cirrhosis, as it is responsible for severe complications and high mortality rates. Tranexamic acid (TXA) may help control the bleeding by counterbalancing cirrhosis-related hyperfibrinolysis. Still, there is a lack of unbiased data to conclude on its efficacy. The aim of this study is to evaluate the efficacy of TXA in the early treatment of acute UGIB in patients with cirrhosis. METHODS AND ANALYSIS: This study is a multicentre, randomised, double-blind, placebo-controlled trial, for adult patients with cirrhosis presenting with an acute UGIB and allocated to one of two arms: TXA or placebo (saline). Physicians from emergency mobile services, emergency departments (EDs) or intensive care units (ICUs) can include patients. Besides study intervention, standard care for UGIB will be performed as recommended. Intervention will consist an intravenous infusion of 10 mL of TXA (1 g) or saline, immediately followed by three identical intravenous infusions over 8 hours each (total dose of 4 g of TXA or 40 mL of placebo over 24 hours). Main analyses will be conducted in intention to treat on every patient included, then in modified intention to treat on patients with underlying lesion of portal hypertension visualised by endoscopy. The main objective is to show efficacy of TXA until day 5 on a composite criterion (bleeding control, rebleeding episodes and mortality). Secondary objectives aim at showing the efficacy of TXA on each individual component of the main outcome measure and others at 6 weeks and later (transjugular intrahepatic portosystemic shunt procedure, cirrhosis-specific complications, length of stay in ICU and in hospital, safety and tolerance of TXA, liver transplantation). Included patients will be followed up to 1 year after inclusion.500 patients will be necessary to show a reduction in the prevalence of the primary outcome from 30% to 18% with a bilateral alpha risk of 5% and a power of 80%. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Comité de Protection des Personnes Ile-de-France 1 (CPP-IDF1). Results will be disseminated via publications in peer-review medical journals and scientific forums. PROTOCOL VERSION: This protocol is based on the latest version, as established on 11 October 2017 and validated by the IRB CPP Ile-de-France 1. TRIAL REGISTRATION NUMBER: NCT03023189.

Development of an online, universal, Utstein registry-based, care practice report card to improve out-of-hospital resuscitation practices.

RATIONALE, AIMS AND OBJECTIVES: Care quality is a primary concern in health field. In France, the care practice report card (CPRC) is compulsory for practitioners. It is the first step towards the culture of excellence. In this context, practitioners have to assess and improve their practices. Competent authorities define registries as reliable sources for CPRC. The first aim of this work is to describe how we designed and built a universally transposable CPRC model based on an Utstein-style cardiac arrest registry. The second aim is to measure the adherence of practitioners to this approach and to show how such a tool can be used in real situation. METHODS: Our report card is adapted from in-hospital CA care quality and safety indicators. We built a 2-section grid. The first part described the quality and completeness of the analysed data. The second part distinguished medical and traumatic CA and assesses care practices. We analysed the practitioners' adherence thanks to a satisfaction survey. Finally, we presented a CPRC case study. RESULTS: This tool was tested in 92 centres gathering 8433 patients. The satisfaction survey showed that this CPRC was well accepted by emergency professionals. We presented an implementation example of this tool in a centre in real-life situation. CONCLUSIONS: We designed and implemented a fully automated CPRC tool routinely usable for Utstein-style CA registries. This CPRC is easily transferable in all other Utstein CA registries. The debriefing report source codes are freely distributed upon request. This tool enables the care assessment and improvement.

Offering the opportunity for family to be present during cardiopulmonary resuscitation: 1-year assessment.

PURPOSE: To evaluate the psychological consequences among family members given the option to be present during the CPR of a relative, compared with those not routinely offered the option. METHODS: Prospective, cluster-randomized, controlled trial involving 15 prehospital emergency medical services units in France, comparing systematic offer for a relative to witness CPR with the traditional practice among 570 family members. Main outcome measure was 1-year assessment included proportion suffering post-traumatic stress disorder (PTSD), anxiety and depression symptoms, and/or complicated grief. RESULTS: Among the 570 family members [intention to treat (ITT) population], 408 (72%) were evaluated at 1 year. In the ITT population (N = 570), family members had PTSD-related symptoms significantly more frequently in the control group than in the intervention group [adjusted odds ratio, 1.8; 95% confidence interval (CI) 1.1-3.0; P = 0.02] as did family members to whom physicians did not propose witnessing CPR [adjusted odds ratio, 1.7; 95% CI 1.1-2.6; P = 0.02]. In the observed cases population (N = 408), the proportion of family members experiencing a major depressive episode was significantly higher in the control group (31 vs. 23%; P = 0.02) and among family members to whom physicians did not propose the opportunity to witness CPR (31 vs. 24%; P = 0.03). The presence of complicated grief was significantly greater in the control group (36 vs. 21%; P = 0.005) and among family members to whom physicians did not propose the opportunity to witness resuscitation (37 vs. 23%; P = 0.003). CONCLUSIONS: At 1 year after the event, psychological benefits persist for those family members offered the possibility to witness the CPR of a relative in cardiac arrest.

Family presence during cardiopulmonary resuscitation.

BACKGROUND: The effect of family presence during cardiopulmonary resuscitation (CPR) on the family members themselves and the medical team remains controversial. METHODS: We enrolled 570 relatives of patients who were in cardiac arrest and were given CPR by 15 prehospital emergency medical service units. The units were randomly assigned either to systematically offer the family member the opportunity to observe CPR (intervention group) or to follow standard practice regarding family presence (control group). The primary end point was the proportion of relatives with post-traumatic stress disorder (PTSD)-related symptoms on day 90. Secondary end points included the presence of anxiety and depression symptoms and the effect of family presence on medical efforts at resuscitation, the well-being of the health care team, and the occurrence of medicolegal claims. RESULTS: In the intervention group, 211 of 266 relatives (79%) witnessed CPR, as compared with 131 of 304 relatives (43%) in the control group. In the intention-to-treat analysis, the frequency of PTSD-related symptoms was significantly higher in the control group than in the intervention group (adjusted odds ratio, 1.7; 95% confidence interval [CI], 1.2 to 2.5; P=0.004) and among family members who did not witness CPR than among those who did (adjusted odds ratio, 1.6; 95% CI, 1.1 to 2.5; P=0.02). Relatives who did not witness CPR had symptoms of anxiety and depression more frequently than those who did witness CPR. Family-witnessed CPR did not affect resuscitation characteristics, patient survival, or the level of emotional stress in the medical team and did not result in medicolegal claims. CONCLUSIONS: Family presence during CPR was associated with positive results on psychological variables and did not interfere with medical efforts, increase stress in the health care team, or result in medicolegal conflicts. (Funded by Programme Hospitalier de Recherche Clinique 2008 of the French Ministry of Health; ClinicalTrials.gov number, NCT01009606.).

Capnography monitoring in nonintubated patients with respiratory distress.

OBJECTIVE: The objective was to assess agreement between end-tidal carbon dioxide values measured by a handheld capnometer (Petco(2)) and values measured by a blood gas analyzer (Paco(2)) in nonintubated patients with respiratory distress in an out-of-hospital setting. METHODS: This prospective study compared Petco(2) values obtained by an end-tidal capnometer (Microcap Plus; Oridion Capnography Inc, Needham, Mass) to Paco(2) values by the Bland and Altman statistical method. RESULTS: A total of 50 patients were included. Continuous Petco(2) monitoring was easily performed in all 50 patients during ambulance transport, but blood gas analysis failed in 1 patient. Agreement between the 2 methods was poor with a bias (mean difference) between Petco(2) and Paco(2) measurements of 12 mm Hg and a precision (SD of the difference) of 8 mm Hg. The gradient between Petco(2) and Paco(2) was greater than 5 and 10 mm Hg in 41 and 25 patients, respectively. CONCLUSIONS: Petco(2) measurements poorly reflected Paco(2) values in our population of nonintubated patients with respiratory distress of various origins.