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).
Management and prevention of anemia (acute bleeding excluded) in adult critical care patients
Ann Intensive Care. 2020;10(1):97
OBJECTIVE Anemia is very common in critical care patients, on admission (affecting about two-thirds of patients), but also during and after their stay, due to repeated blood loss, the effects of inflammation on erythropoiesis, a decreased red blood cell life span, and haemodilution. Anemia is associated with severity of illness and length of stay. METHODS A committee composed of 16 experts from four scientific societies, SFAR, SRLF, SFTS and SFVTT, evaluated three fields: (1) anemia prevention, (2) transfusion strategies and (3) non-transfusion treatment of anemia. Population, Intervention, Comparison, and Outcome (PICO) questions were reviewed and updated as needed, and evidence profiles were generated. Analysis of the literature and formulation of recommendations were then conducted according to the GRADE(®) methodology. RESULTS The SFAR-SRLF guideline panel provided ten statements concerning the management of anemia in adult critical care patients. Acute haemorrhage and chronic anemia were excluded from the scope of these recommendations. After two rounds of discussion and various amendments, a strong consensus was reached for ten recommendations. Three of these recommendations had a high level of evidence (GRADE 1±) and four had a low level of evidence (GRADE 2±). No GRADE recommendation could be provided for two questions in the absence of strong consensus. CONCLUSIONS The experts reached a substantial consensus for several strong recommendations for optimal patient management. The experts recommended phlebotomy reduction strategies, restrictive red blood cell transfusion and a single-unit transfusion policy, the use of red blood cells regardless of storage time, treatment of anaemic patients with erythropoietin, especially after trauma, in the absence of contraindications and avoidance of iron therapy (except in the context of erythropoietin therapy).
Application of tourniquet in civilian trauma: systematic review of the literature
Anaesthesia, Critical Care & Pain Medicine. 2018;37((6):):597-606.
INTRODUCTION The effectiveness of a tourniquet (TQ) in case of extremity haemorrhages is well recognised to prevent death on the battlefield. However, little is known about the usefulness of TQ in civilian trauma settings, including terrorist attack situations. The aim of this systematic review was to analyse the evidence-based medical literature in order to precise the use of TQ in the management of extremity haemorrhages in civilian setting. METHODS Analysis of all studies published until 12/31/2016 on the Embase, Medline and Opengrey databases. To be included, studies had to contain descriptions, discussions or experiences of TQ application in civilian setting. The quality of the studies was evaluated using the PRISMA and the STROBE criteria. RESULTS Of the 380 studies identified, 24 were included. The overall level of evidence was low. 3028 TQ placements were reported. Most of them concerned the Combat Application Tourniquet: CAT(R). Haemorrhages implied in the use of TQ were almost exclusively traumatic, most of the time regarding young men (27-44 years old). Effectiveness rates of TQ varied between 78% and 100%. Complications rates associated with the use of TQ remained low, even when used in elderlies or patients with comorbidities. Finally, caregivers reported a common fear of adverse effects, while reported complications were rare (<2%). CONCLUSION This systematic review revealed TQ to be an effective tool for the management of extremity haemorrhages in civilian trauma, associated with few complications. Larger studies and dedicated training courses are needed to improve the use of TQ in the civilian standards of care.
Tranexamic acid as part of remote damage-control resuscitation in the prehospital setting: a critical appraisal of the medical literature and available alternatives
The Journal of Trauma and Acute Care Surgery. 2015;78((6 Suppl 1)):S70-5.
BACKGROUND Hemorrhage remains the leading cause of preventable trauma-associated mortality. Interventions that improve prehospital hemorrhage control and resuscitation are needed. Tranexamic acid (TXA) has recently been shown to reduce mortality in trauma patients when administered upon hospital admission, and available data suggest that early dosing confers maximum benefit. Data regarding TXA implementation in prehospital trauma care and analyses of alternatives are lacking. This review examines the available evidence that would inform selection of hemostatic interventions to improve outcomes in prehospital trauma management as part of a broader strategy of "remote damage-control resuscitation" (RDCR). METHODS The medical literature available concerning both the safety and the efficacy of TXA and other hemostatic agents was reviewed. RESULTS TXA use in surgery was studied in 129 randomized controlled trials, and a meta-analysis was identified. More than 800,000 patients were followed up in large cohort study. In trauma, a large randomized controlled trial, the CRASH-2 study, recruited more than 20,000 patients, and two cohort studies studied more than 1,000 war casualties. In the prehospital setting, the US, French, British, and Israeli militaries as well as the British, Norwegian, and Israeli civilian ambulance services have implemented TXA use as part of RDCR policies. CONCLUSION Available data support the efficacy and the safety of TXA. High-level evidence supports its use in trauma and strongly suggests that its implementation in the prehospital setting offers a survival advantage to many patients, particularly when evacuation to surgical care may be delayed. TXA plays a central role in the development of RDCR strategies.