ANZCTR search results

Infants and children requiring surgery often experience significant blood loss. Blood consists of several components that are required to maintain normal physiological processes. Included within our blood are red blood cells, white blood cells, platelets and proteins. One of the main roles of blood is to maintain haemostasis, a balance to ensure blood clots appropriately when tissue trauma occurs. When large volumes of blood loss occur, components of blood responsible for forming a clot are lost and require replacement to ensure cessation of blood loss and tissue healing. During surgery for craniosynostosis, due to the nature of the surgery, a large volume of blood is lost. Anaesthetists are very experienced in observing the blood loss and replacing blood products to ensure appropriate amount of red blood cells are present and that blood haemostasis is maintained, keeping the child safe. At the Queensland Children’s Hospital, we found that up to 33% of patients received blood products to assist with maintaining haemostasis. Typically, anaesthetists will use blood tests that are sent to the laboratory to determine appropriate clotting function. Typically, a child’s blood loss occurs quicker than the return of accurate results, therefore blood products used to assist clotting, including fresh frozen plasma, cryoprecipitate, platelets will be replaced based on perceived total volume of blood lost. Recently point of care viscoelastic haemostatic assay utilising a ‘thromboelastogram, (TEG)’ has been incorporated into clinical practice to guide transfusion of blood products responsible for haemostasis. In an audit of our clinical practice for craniosynostosis 43% of cases utilised TEG to guide haemostatic therapy. As such we have varied clinical practice of clinicians within our department. The evidence regarding the benefit of viscoelastic haemostatic assays in the elective paediatric surgical population is limited. To date there have been no high-quality studies comparing an anaesthetic physician guided, utilising standard coagulation tests, to a viscoelastic haemostatic assay guided transfusion strategy. We aim to compare the two techniques using a randomised controlled trial in infants having surgery for craniosynostosis. Initially our study at Queensland Children’s Hospital will be a feasibility study. If it can be conducted well, we plan to incorporate other paediatric hospitals within Australia to increase patient recruitment.

This study will aim to assess the impact of a progressive, structured exercise program in patients with symptomatic AF in a randomised controlled trial. The study intervention will be assessed by the maintenance of sinus rhythm post-ablation, when compared with standard medical care. The primary endpoint of this study is the recurrence of any atrial arrhythmia, off anti-arrhythmic drugs (AADs) in the 18-months post-ablation. We hypothesise that exercise training will reduce arrhythmia recurrence following ablation, compared to standard medical care alone. The key secondary endpoints will include atrial structural remodelling, peak oxygen consumption and AF symptom severity.

Banana pseudo stem tender core contains nutritional compounds that are crucial for health. This project aims to assess the feasibility and tolerability of a dietary supplement derived from banana pseudo stem tender core, which is high in fibre, polyphenols and minerals, and its effect on clinical measures, gut microbiome, and urine markers. To this end, a randomised controlled trial with 46 (23 in each arm) participants will be conducted. Participants will be randomly allocated to receive either the banana pseudo stem powder (intervention) or maltodextrin (placebo) over a period of 4-weeks. Participants, investigators, assessors, and study statistician will be blinded to group allocation.

This study addresses the question of whether an augmented version of a psychological intervention (Cognitive Behaviour Therapy combined with augmentation strategies; CBT/A) to reduce severity of Prolonged Grief Disorder (PGD) more than standard CBT. CBT/A is a novel extension of the gold standard treatment of Prolonged Grief by providing training in emotion tolerance skills and positive affect awareness. The key question of the study is the extent to which this modification to CBT can promote better outcomes relative to standard CBT. This study hypothesises that CBT/A will result in greater reductions in Prolonged Grief than CBT at 6 months following treatment. Participants with PGD will be randomized to 11 sessions of standard CBT or Augmented CBT.

We do not have adequate solutions for upper-limb recovery following stroke. Insufficient therapy is delivered during critical periods of recovery, despite stroke being a life-long disability. Upper-limb recovery is possible, with clear evidence that appropriate amounts of practice are important for improvement to occur. The purpose here is to deliver an intense burst of training, comprising 90h of rehabilitation over a 5-week period. We anticipate that people who receive this intense burst of training will achieve improved upper limb function.

Inulin is a type of dietary fibres commonly found in plants such as Jerusalem artichoke and garlic. Compared to dietary fibres that are non-inulin based such as apple and watermelon, inulin-based fibres have been shown to improve sugar control and digestive health, aid weight loss and improve lipid profiles. From animal studies, we also known that the size of inulin also affects how quickly it gets to the lower gut and is being broken down into various compounds that can produce a positive health impact. However, little research has been done on humans using actual dietary fibres. This study is designed to investigate how quickly different types of inulin and non-inulin based fibres are being digested. We will also test how these different types of fibres alter the biochemical changes in the body.

Every day, two new Australians are diagnosed with motor neuron disease (MND) - a fatal neurodegenerative disease characterised by the progressive degeneration and death of motor neurons that leads to muscle weakness, physical disability, and ultimately death. The aim of this project is to understand if exercise can slow the neurodegeneration in MND, by investigating the neuroprotective potential of 16 weeks of carefully prescribed exercise on the brain, spinal cord, and muscle of patients with MND. Participants enrolled in the study will be randomly allocated to a training (TRAIN) or control (CTRL) group. Participants in the TRAIN group will perform 16 weeks of exercise training, 3 times per week, at the Victoria University Clinical Exercise and Rehabilitation (VUCER) clinic in Footscray. Participants in the CTRL group will continue their standard of care. Before, at the end of the exercise training or standard of care period of 16 weeks, and at 24 weeks, which equates to 8 weeks following cessation of intervention, all participants will be evaluated with brain imaging (magnetic resonance imaging, MRI), neurophysiological (surface electromyography, EMG) and muscle strength measurements, aerobic fitness, respiratory and functional tests. Quality of life (QoL), fatigue and functional questionnaires will be also administered to all participants. In a subgroup of participants, resting needle biopsies will be obtained from the vastus lateralis muscle in the thigh, before and at the end of 16 weeks of intervention. We hypothesise that individuals who exercise will present a reduced motor neuron degeneration in the brain and spinal cord, and a preserved skeletal muscle mitochondrial function and content, with respect to individuals in the control treatment (standard of care). This will result in delaying the disease progression by maintaining strength, physical function and independence. This multimodal approach of investigating the neuroprotective effect of exercise in those with MND will provide a fundamentally new understanding that has the potential to alter the role of exercise in the treatment of MND, and could be used to identify new targets for neuroprotective therapeutics.

The link between oral health and cardivascular disease has been proven. Currently, there is no oral health education within cardiac rehabilitation facilities within Western Sydney Local Health District. Patients living with cardiovasuclar disease and gum disease are at an increased risk of a future cardiac event. Introducing oral health education into this vunerable poopulation may reduce their gum disease and with it their future cardiac event risk.

Single centre, adaptive design, open-label, two period crossover, study to evaluate the safety, pharmacokinetics and ex vivo antibacterial effects of RECCE®327 in healthy male and female volunteers. This study consists up to 4 cohorts with 4 participants at each dose level. The first cohort will involve two infusion rates 45 minutes (Period A) and 30 minutes (Period B) of RECCE®327 at a concentration of 4 mg/ml. Each participant will begin with a single dose with RECCE®327 intravenously over 45 minutes, followed by 48 hours safety surveillance and PK data collection. Safety assessments will be performed by the investigational site study staff and reviewed (sign off) by the PI or designee before the second dose of RECCE®327 infusion over 30 minutes with the same dose level and dose concentration and with a minimum time elapsed of 48 hours from the start of the first dose to the second dose. For the subsequent cohort, a non-DSMB committee will review the safety and PK data (latter if available), and may suggest an adjustment of dose level, infusion rate and / or concentration of the RECCE®327 before proceeding to the next cohort. The non-DSMB committee may determine not to proceed with additional cohorts as well. the aim of this study is to investigate possible safety dose of RECCE®327 in various dose levels and infusion duration.

What is the project about? This research project aims to evaluate the outcomes of two social media psychoeducation videos. We are inviting people who have had an Instagram account for at least 1-week by the time of study participation, are over the age of 16 years, and are fluent in English. Participants are also required to have access to a smart phone, from which they are able to access their Instagram account. During the intervention, you will be requested to complete a survey to collect demographic and well-being information, before watching one of two (10 minutes or 13 minutes long) online social media psychoeducation videos and then engaging in 10 minutes of Instagram use (using your personal account). You will then be invited to complete another survey immediately following and again 3 days later. How much time will my involvement in the project take? The initial experiment and surveys will take approximately 40 minutes. The follow-up survey is expected to take 5 minutes.