Prothrombinex-VF® for coagulopathy of liver disease in acutely bleeding patients; Too much of a good thing?

Chronic liver disease (CLD) is prevalent in Australian society and is the 11th leading cause of premature death (1). Thirty eight percent of patients experience gastrointestinal bleeding (GI) as a complication(2). The underlying balance between bleeding and clotting tendency is altered in chronic liver disease, making management of acute bleeding challenging in the emergency setting(3). There is a lack of high-quality evidence to guide the best combination of blood products and other medications to stop bleeding(4).

Prothrombinex®-VF is a blood product which can help to improve the level of clotting factors in the body thereby reducing bleeding tendency. It is indicated for anticoagulant reversal in acute bleeding(5). In practice many emergency physicians have used the product for patients with chronic liver disease who present with acute bleeding, although it is not licensed for this indication(6).

A retrospective Queensland study performed by this author showed that half of Prothrombinex®-VF usage for liver disease was in the emergency department by emergency physicians. It suggested that the product makes little impact on reversal of laboratory blood clotting tests and it raised important safety concerns regarding the develop of a syndrome of accelerated bleeding and clotting concurrently(6).

This expanded statewide audit of Prothrombinex®-VF in chronic liver disease in Queensland seeks to define efficacy and safety of the product. There is no statewide guideline for Prothrombinex®-VF and this data will contribute valuable information to developing future guidance for clinicians.

Predicting in-flight hypotension in aeromedical trauma patients

In-flight hypotension (low blood pressure) leading to patient deterioration is a common and challenging clinical problem in aeromedical trauma patients. Predicting this risk is currently primarily based on clinical gestalt, without specific validated risk prediction tools. The Triage Revised Trauma Score (TRTS) is a clinical risk prediction tool calculated using only vital signs, making it well suited to the resource-limited pre-hospital environment.

A Life Flight Retrieval Medicine internal audit in 2021 suggested an association between the TRTS and in-flight hypotension for trauma patients. Based on these preliminary findings, this study will address the research question, “what is the relationship between pre-flight TRTS and in-flight hypotension in trauma patients undergoing aeromedical retrieval?”.

Knowledge gained from this study may allow aeromedical doctors to make more informed decisions about their patients before aeromedical transport.

Composition, Quality and Delivery of Major Haemorrhage Protocols (MHP) and critical bleeding clinical practice guidelines in hospitals across Queensland Health

Major bleeding is a leading cause of death in trauma patients. Blood product replacement is a key component of damage control resuscitation aimed at limiting coagulopathy until definitive control of bleeding is achieved. Although Major Haemorrhage Protocols (MHP) are now widely used in the initial resuscitation of traumatically injured patients (1), protocols can vary based upon individual institutions' capabilities and processes.

Within Australia, the National Blood Authority 2011 Patient Blood Management Guideline Module 1: Critical Care/ Massive Transfusion (2) recommended institutions develop standardized MHP to guide clinicians regarding the dose, timing and ratio of blood component therapy for bleeding trauma patients. However, it is currently unknown if these guidelines are implemented and if so, what institutional variations occur. While the guidelines provide a robust review of the evidence base for MHP, there is little information about the logistics of MHP implementation.

Our project aims are firstly to compare the available trauma bleeding protocols across Queensland for content and quality. Secondly, we wish to understand the institution's capabilities of delivering an MHP in terms of the structure and processes available to them. Thirdly we want to explore the experiences of clinicians involved in delivering an MHP for trauma patients in both tertiary, rural and remote hospitals within Queensland.

Expected benefits are to identify potential disparity of care for trauma patients in terms of MHP content, availability of resources and access to blood products. This information can help guide improvements in education, blood products availability and cost-effective care across Queensland.

Patterns of prescription opioid use following ED presentation for minor road traffic crash injury

Australia is five years behind the US’ opioid epidemic (>15,000 US deaths/year). General Practitioners and EDs frequently prescribe opioids for isolated musculoskeletal pain (e.g. “whiplash”) from RTCs, but this potentially inappropriate opioid prescribing likely leads to unnecessary opioid exposures. In the last decade, opioid overdoses in Australia have more than doubled. 75% of opioid overdose deaths involve prescription opioids; annual death rates exceed road traffic deaths.

Emergency Departments (EDs) commonly prescribe opioids on discharge for patients with non-serious road traffic crash (RTC) injury. This potentially compromises recovery and contributes to continued opioid use and potential misuse in the community.

The project will address the gap on whether, or for how long, short courses of opioids are continued following acute non-serious RTC injury, and to what extent this causes subsequent problems, by measuring patterns of use, impacts, and costs of opioid use in EDs and following discharge over a 12-month period.

The project will provide the first Australian data on opioid prescribing in ED for acute minor RTC injuries and link ED data to community data to explore longitudinal prescribing patterns post RTC.

uSing Meditation App to Reduce ED occupational sTress (SMART) trial

Our study aims to test whether a mindfulness program delivered by a smartphone app can reduce occupational stress levels among Emergency Department (ED) staff. This study will recruit staff at two regional EDs. Staff will practice short session mindfulness daily, for four weeks, using a smartphone meditation app. The study will determine if, by using the app, staff levels of occupational stress are reduced and overall wellness increased. The levels of stress reduction will be compared before and after the intervention.

Working in an ED can be stressful. It has been suggested that up to half ED doctors and nurses may suffer from burnout due to high workload, overcrowding and limited resources. Staff stress and its negative consequence pose challenging issues to both individual clinicians and healthcare organisations. Sub-optimal wellness of staff is closely associated with poor patient care, more medical incidents and a high staff turnover rate. One way to reduce staff stress levels is by promoting staff coping skills and wellness. Mindfulness is a mental technique to focus self-awareness at the present moment and non-judgmentally. It has been used widely to promote staff workplace wellness. Smartphone apps are a relatively new delivery method for mindfulness that has not yet been tested among ED staff.

Fluid resuscitation in emergency patients with sepsis and hypotension (ARISE Fluids)

The question of fluid volume in resuscitation has been identified as the top priority in sepsis research by emergency physicians in the United Kingdom, Australia and New Zealand. Guidelines and sepsis pathways recommend an initial intravenous (IV) fluid bolus of 30ml/kg isotonic crystalloid for patients with sepsis and hypotension. However, there is a lack of evidence from clinical trials to support this strategy. Both observational data as well as randomised studies suggest there may be harm associated with injudicious use of fluids in sepsis. Since there is equipoise regarding a more liberal or restricted fluid volume resuscitation as first line treatment for sepsis-related hypotension, we conducted the pilot multicentre REstricted Fluid REsuscitation in Sepsis-associated Hypotension (REFRESH) trial comparing a restricted fluid protocol with early initiation of vasopressor support against standard guideline care.

The data from REFRESH will inform feasibility of a large, multicentre phase III study. However, further ground work is essential for the optimal design of a Phase III trial that will provide valuable information on feasibility (road test recruitment rate and screening processes) as well as refinement of the protocol (sample size estimation, processes of care, prevalence of the population of interest, real world clinical practice regarding fluid use).

In this ARISE Fluids study, we aim to provide more insight into current practice by conducting a bi-national multi-site prospective observational study of fluid administration in (suspected) sepsis and hypotension in the Emergency Departments of Australia and New Zealand hospitals. Sites have been selected on the basis of having expressed interest in participating in a phase III trial.

International mass gathering impact on Gold Coast Hospitals’ emergency departments

Queensland is known for its ability to attract mass gathering events of international significance, such as the 2018 Commonwealth Games, 2023 FIFA Women’s World Cup and the 2032 Olympic Games. Such events have the potential to impact the normal operational capacity of our emergency health services.

The objective of this study is to describe the impact of the 2018 Commonwealth Games on the emergency departments in the Gold Coast region. This research has two key aims, which align with two discrete but related studies:

Study 1 Aim: To describe and determine whether changes in patient, health service, and economic outcomes occur before, during and after the Commonwealth Games.
Study 2 Aim: To explore healthcare staff experience of planning, preparedness and lessons learnt from the Commonwealth Games.

Fibrinogen Early In Severe Trauma in children studY (FEISTY Junior)

Traumatic injuries in children are a leading cause of death and disability in Australia. In high income countries, 40% of child deaths are because of traumatic injuries. Fibrinogen is one of the key clotting factors that need to be replaced in severe traumatic bleeding.

Currently, fibrinogen is replaced using cryoprecipitate; a blood product obtained from healthy volunteer donors. This is a precious resource that is stored frozen in the blood bank; it can take a long time to administer and place significant strain on blood banks. Fibrinogen concentrate (FC) is an alternative product used to assist in blood clotting. It is a product that is derived from blood plasma but stored in powder form and can be reconstituted at the bedside and given quickly. The study will investigate whether it is quicker to administer FC than cryoprecipitate, which may reduce haemorrhage and improve outcomes.

This study will enrol 30 children from three major paediatric trauma centres in Queensland admitted with severe traumatic bleeding. Time to administration of fibrinogen replacement and the effect of fibrinogen levels will be measured.

Domestic and family violence screening in the emergency department

Domestic and family violence (DFV) against women is the number one cause of hospitalisations in Australian girls and women aged 15-54 years. It is also the number one cause of death and disability in women aged 15 to 44. Although most victims of fatal DFV access health services in the 24 months prior to their deaths, many victims living with DFV go unnoticed in the community. Health care providers are well placed to identify DFV victims and refer them to appropriate services. The ED has been described as a good place to undertake identification of DFV victims in several published research papers. Yet, how to do this remains controversial, and there are no standard protocols in place in our EDs. In this project, we aim to describe the current DFV health practice culture in five Queensland EDs. Knowledge, beliefs, and attitudes, as well as what’s actually happening to detect cases of DFV, will be assessed among our front-line ED social workers, nurses, and doctors. We aim to determine how many presentations to ED are identified and referred to social worker services for DFV. Ultimately, this research will both raise awareness about the potential of the ED to detect DFV, and will help pave the way forward to a well-informed and structured ED DFV screening program for Queensland, with applicability internationally.

FEISTY – Fibrinogen Early In Severe Trauma study

This clinical trial aims to improve the quality of the resuscitation of patients with traumatic haemorrhage. We are enrolling 100 patients from four major trauma centres in Queensland. Patients admitted with severe traumatic bleeding will be given either Fibrinogen concentrate or cryoprecipitate. Time to administration of these products and effects on blood fibrinogen levels will be measured. We are using innovative technology to identify hypofibrinogenaemia; we will provide data to define the optimal method of replacement and monitoring of the end points of resuscitation; and provide data on the role of fibrinogen concentrate and its use in traumatic haemorrhage. We are also exposing a broad range of ED physicians to potential practice changing research that may be translated to use in other patient groups with critical bleeding.

More than 7000 Australians are treated for severe trauma every year. Major bleeding in the setting of trauma is associated with poor outcomes and increased rates of death. Severe trauma causes a decrease in the factors within the blood that helps clots to form and stop bleeding. This loss of clotting factors is associated with worse outcomes and it is proposed that early replacement of these factors may reduce bleeding and improve outcomes. Fibrinogen is one of the key clotting factors that needs to be replaced in severe traumatic bleeding. Currently fibrinogen is replaced using cryoprecipitate; a blood product obtained from healthy volunteer donors. This is a precious resource that is stored frozen in the blood bank; it can take a long time to administer and place significant strain on blood banks. Fibrinogen concentrate (FC) is an alternative product used to assist in blood clotting. It is stored in powder form, can be reconstituted at the bedside and given quickly. The study will investigate whether it is quicker to administer FC than cryoprecipitate, which will reduce haemorrhage and improve outcomes. With positive impact for both large urban metropolitan areas and remote isolated communities.