ANZCTR search results

The aim of this research is to establish how good current x-ray methods are at identifying artery wall dissections that are severe enough to require further treatment. Dissections are tears of the inner layer of the artery wall caused by angioplasty (the deliberate stretching open of a blocked or narrowed artery using a balloon placed inside the artery). Dissection is a common complication of treatment with most being minor and requiring no further action, however some dissections are severe enough that they need further treatment. Currently very little is known about the accuracy of the current x-ray-based methods of identifying severe dissection. We also don’t know how much variation in diagnosis of dissection there is between doctors or whether there is a difference in the results of treatment at one year between mild and severe dissections. In this research project we will be obtaining several other measurements in addition to x-rays (including conventional ultrasound imaging, intravascular ultrasound (a miniaturised form of ultrasound mounted on a catheter that is placed within the artery), and pressure measurments within the artery) to assess the severity of dissections seen after initial treatment. We will also follow up participants for one year after the treatment to check on the success of the treatment. If current x-ray methods are found to perform poorly, it may be possible to develop better methods using some of these other measurement methods. We hope that this research will improve the diagnosis of dissection in the future and ensure that patients in the future will have better outcomes from their angioplasty treatment.

People with haematological malignancies are at increased risk of severe disease and death from COVID-19. New vaccines from Pfizer and AstraZeneca are reporting high immunogenicity and efficacy in clinical trials, but there is lack of data regarding how well people with haematological cancers respond to vaccines, to what extent and how durable responses may be. It seems reasonable that responses will differ in patients with haematological malignancy, based on both disease factors and factors related to specific anti-cancer treatments. Follicular lymphoma (FL) and Waldenstrom Macroglobulinaemia (WM) are two low grade non-Hodgkin lymphomas that offer potential models to study the impact of immunocompromisation on the immunogenicity of the COVID-19 vaccines. This study, combined with our evolving understanding of which types of vaccine responses are most important in conferring long-term protection against COVID-19, will allow people with FL and WM to make better informed decisions about treatment induction and maintenance options when indicated. It will also provide patients who have already completed treatment a better idea of how much protection to expect and what additional precautions might be required (e.g. preventative pharmacological agents in development, ongoing isolation if necessary, or additional vaccination if evidence emerges to support that).

Venous thromboembolism (VTE) is a condition whereby a blood clot forms inappropriately in the veins. This clot may dislodge from its point of origin and be carried to the lung vasculature, which may be a fatal event. It has been estimated that the Australian annual incidence of VTE is 0.83 per 1000 individuals and is associated with significant morbidity and health related economic costs. In 2008, the estimated cost to the Australian economy was $1.7 billion dollars. Venous thromboembolism may be provoked by major surgery. The risk of surgically provoked VTE may be mitigated by the combined use of mechanical thromboprophylaxis, as recommended by the 2012 American College of Chest Physicians (ACCP) clinical practice guidelines and more recently, the 2019 American Society of Hematology (ASH) clinical practice guidelines. Despite this, there is no clear recommendation as to the type of mechanical thromboprophylaxis that should be used, with either or both graduated compression stockings (GCSs) or sequential calf compression devices (SCCDs) used. We wish to perform a cohort study of all laparoscopic cholecystectomies (elective and emergency) with a standardized mechanical prophylaxis protocol, to determine if we can maintain a low rate of VTE on SCCDs alone compared with the historical cohort of patients managed with combined SCCDs and GCSs, whilst maintaining safety including the risk of bleeding. The hypothesis of this study is that there is no difference between combined SCCDs and GCSs when compared with SCCDs alone. If this is true, GCSs could be removed from normal care, reducing GCS related complications and producing substantial cost savings for hospitals.

The DELTA study is a double blinded parallel arm randomised controlled trial designed to test the hypothesis that a two-day course of oral dexamethasone in mild to moderate COVID-19 patients results in fewer COVID-19 related hospitalisations, intensive care unit admissions and death; and reduced time to self-reported symptom resolution. Once patients have consented to participate in the study, they will be randomised to receive either 6mg oral dexamethasone or 150mg thiamine (placebo). Study information will be collected from electronic Medical Records (eMR). Only routinely collected data will be used for this study, and will include disposition, intensive care admission, ventilation days and total hospital length of stay. Data managers and/or clinical nurse consultants will assist with data extraction. Data will be collected and entered into SLHD RedCap. Data analysis will follow.

Intravenous (IV) antibiotic therapy is a very common reason for inpatient admissions. Traditionally a short peripheral intravenous cannula (PIVC) (<4 cms) has been the ‘default’ device for short term (1-14 days) antibiotic therapy however 33 – 54% of short-PIVCs fail during treatment, resulting in delayed antibiotic administration and repetitive insertion procedures. Interruption to antibiotic treatment has been linked to re-emergence of infectious disease, increased hospital stays, and antimicrobial resistant organisms. Recently, longer peripheral IV devices (4.5 -6.4 cms) have been introduced for short-term peripherally-compatible IV therapy. While observational data appears to suggest that long-PIVCs (with a greater catheter length within the vein) out-perform short-PIVCs, this has not been evaluated in a randomised controlled trial (RCT). We will conduct a single centre, two-arm, parallel RCT whereby initially 70 patients will be randomised to receive either a short-PIVC (control) or long-PIVC (intervention) for antibiotic administration. Should feasibility criteria be met a total 192 will be randomised to a fully powered study. We the investigators hypothesise that long-PIVCs will result in less antibiotic therapy interruption, with patients requiring fewer subsequent PIVC insertions.

This study aims to assess the clinical benefit of local ablative therapy (LAT) following initial standard first-line systemic treatment for metastatic colorectal cancer. Who is it for? You may be eligible for this trial if you are aged 18 years or over, have metastatic colorectal adenocarcinoma, have between more than 3 lesions, and are receiving first-line systemic treatment. Study details Participants will receive metastasis-directed LAT such as surgery, radiotherapy, microwave or thermal ablation following 3-6 months of initial standard first-line systemic treatment, Those receiving LAT will return to systemic treatment 16 weeks after enrolment only if they did not complete 6 months of first-line treatment prior to enrolment. Information on progression-free survival and treatment outcomes will be collected. Data from this study will inform investigators of the potential benefit of local ablative therapy in the therapeutic setting for metastatic colorectal cancer.

This study aims to observe acute muscle loss in patients with an acute severe traumatic brain injury over the first 28 days. To date acute muscle loss following the first 7 days following traumatic brain injury has not been reported. This study will assist to determine if there is an association between acute muscle wasting and functional impairments following a severe traumatic brain injury. The study will also determine if enteral or parenteral nutritional intake whilst admitted to intensive care (energy and protein) is associated with acute muscle wasting. This observational study is expected to lay the foundation for future interventional studies to assess the effect of exercise or nutrition (or a combination of both) on muscle loss and functional recovery following a severe traumatic brain injury.

This study will compare treatment satisfaction with Omnipod-DASH insulin pump with usual care with insulin pump therapy without sensor or multiple daily insulin injections in adults with Type 1 diabetes. We hypothesize that adults with Type 1 diabetes will report a more positive experience using Omnipod-DASH compared with their usual care.

Autism is a lifelong neurodevelopmental disorder characterised by differences in social communication, repetitive and restricted behaviours and sensitivities to sensory input (Diagnostic and Statistical Manual of Mental Disorders 5th ed: DSM-5; APA, 2013). Along with autism symptomology, autism is linked to a greater incidence of insomnia, with the prevalence estimated at 60- 86% in school aged children, compared to 5-30% among their non-autistic peers (Paine & Gradisar, 2011; Papadopoulos et al., 2019; Liu et al., 2006). Consequences of poor sleep include behavioural problems, impaired adaptive behaviour, psychopathology and exacerbated autism symptomology (Paine & Gradisar, 2011; Papadopoulos et al., 2019). Resultingly, effective treatment for insomnia is imperative in order to reduce negative consequences. Cognitive Behavioural Therapy for insomnia (CBTi) is recommended as a primary treatment for insomnia (American Academy of Sleep, 2005) and has demonstrated efficacious outcomes (Quaseem et al., 2016). However, there is scant research on CBTi as a treatment for insomnia among individuals with autism, with the majority of studies focusing on pharmaceutical options (Cortesi et al., 2012). Therefore, the present study aims to establish the efficacy of Cognitive Behaviour Therapy for Insomnia (CBTi) in children aged 7-12 with autism, compared to a waitlist control group of children aged 7-12 with autism. Hypotheses Children who receive CBTi will have significantly greater improvements in sleep parameters including sleep onset latency, wake after sleep onset, sleep duration and sleep efficiency compared to a waitlist controlled autistic group. Additionally, children who receive CBTi will have significantly greater improvements in anxiety, depression and daytime sleepiness compared to the waitlist controlled autistic group.

Following bowel resection due to cancer, up to 80% of patients will experience variable and unpredictable bowel function and symptoms termed as Low Anterior Resection Syndrome (LARS). The exact mechanism of LARS remains unclear and currently there is no standard treatment. Research shows that the gut microbiome, also known as gut bacteria, is changed in patents following bowel cancer and may be linked with LARS and the changes in bowel function and symptoms experienced. This program of research therefore aims to examine the effect of Faecal Microbiota Transplantation in LARS symptoms, the gut microbiome and quality-of-life. Who is it for? You may be eligible for this study if you are aged 19 years or older, have had an ileostomy reversed with a background of low anterior resection or ultra-low anterior resection due to adenocarcinoma of the colon or rectum, and are experiencing symptoms of minor or major LARS. Study details Participants will be randomised (i.e. allocated by chance) to receive one of two different doses of faecal microbiota transplant, or standard care. Faecal microbiota transplant involves administering faecal matter via a syringe using colonoscopy, which requires insertion of a flexible tube into the rectum, and will take an addition of approximately 5 minutes to your routine colonoscopy to complete. Participants allocated to standard care will not receive a faecal microbiota transplant. All participants will answer a number of questionnaires about bowel function and quality of life, and will provide a stool sample for analysis at baseline and week 4 of the study. Participants will also provide a blood sample to assess their immune response and signs of inflammation at baseline and week 4 of study. It is hoped that this research will show that faecal microbiota transplant is an effective treatment for reducing symptoms of LARS and improving quality of life in patients who have undergone a low anterior resection.