ANZCTR search results

This research project is being conducted to evaluate the bioequivalence and biosimilarity of SBS6002 to Neulasta when administered to healthy participants by comparing PK, PD, safety and tolerability.

Post-partum haemorrhage (PPH) is a common obstetric complication and a major cause of maternal mortality and morbidity in Australia. Treatment of PPH often involves significant healthcare resources, including blood products, operating theatre time, prolonged hospital length of stay, and in severe cases, admission to intensive care. PPH is often associated with, and is exacerbated by, abnormalities of haemostasis. Traditional coagulation tests are insensitive at predicting severity of PPH and guiding its management, with a paucity of evidence supporting their use for transfusion management in the peri-operative setting. Rotational thromboelastometry (ROTEM) is a point-of-care test of whole blood coagulation that provides rapid information about time to clot formation, strength of clot and presence of fibrinolysis. ROTEM can be used to help guide replacement coagulation treatments in peri-operative settings. ROTEM was introduced in June 2016 in the operating suite at Sunshine Hospital, alongside a transfusion algorithm. This study aims to examine the effect that the introduction of ROTEM-guided transfusion management has had on the utilisation of blood products and on clinical outcomes in patients with PPH requiring surgical management. This will help us to better understand the role and benefits of ROTEM in the peri-operative setting, which will in turn benefit patient care by better informing future management of PPH and related clinical conditions.

Patients with type 2 diabetes are at high risk of cardiovascular disease. Treatments targeted at lowering glucose may reduce the risk of cardiovascular disease, however other approaches are needed as patients remain at an elevated residual risk of cardiovascular events. There is evidence that fluctuation in blood pressure (blood pressure variability) is an important risk factor for cardiovascular disease, such that substantial changes over time are detrimental and lead to an increased risk of cardiovascular disease. Metformin is a drug that has been used for diabetes for many years, though the mechanism of action remains incompletely understood. Early studies with this drug suggested that this particular agent was effective at reducing cardiovascular events and there is some evidence that metformin can modify both blood pressure, and gut responses following a meal. We are interested in looking to see whether metformin could reduce blood pressure fluctuations induced throughout the day, and in particular following meals. Information from this study will help guide further research into mechanisms behind and potential novel approaches to cardiovascular disease and blood pressure in diabetes. Given recent interest in the bacteria in the gut and how this influences health and blood sugar control, we will also look at the effect of metformin on bugs in the gut (microbiome).

RETHINK is a cohort study to REconsider THe Factors that INfluence stroKe recovery. The hypothesis is that there are domain specific biological biomarkers and psychosocial determinants that predict clinically relevant recovery after stroke. The primary aim of this study is to investigate and characterise biomarker and psychosocial determinants for upper limb motor deficits that associate with favourable and unfavourable recovery at multiple time-points following ischaemic stroke. These common deficits affect upwards 70% of those with a stroke making it a particularly pertinent focus of study. In addition to upper motor deficits, RETHINK will investigate stroke recovery across specific domains (lower limb, cognitive-aphasia, neglect, sensory) using a global approach. Participants will be asked to provide blood and microbiome samples at study enrolment and at primary and secondary time-points. Participants will also be asked to complete one Patient Reported Outcome Measure (PROMS) online survey about quality of life and for a small subgroup, will be invited to participate in one face to face interview about their experiences in the study and with the outcome metrics.

While women comprise a small (8%), but rapidly growing segment of the prisoner population, 57% of incarcerated Aboriginal women were incarcerated for a violent offence, much higher than for non-Aboriginal women (33%). Violent women offenders pose a significant challenge to custodial authorities as they have more complex physical and mental health needs than men. The study aims to determine the effectiveness of a targeted substance, mental health and violence intervention (Beyond Violence) in reducing re-offending at 24 months among Aboriginal and non-Aboriginal women with convictions for a violent offence.

This is a prospective, cross-over clinical trial to determine the effect of filters, myopia control spectacles and soft contact lenses on the contrast sensitivity function. Up to 30 prototype designs may be assessed during the study. Up to 20 participants (minimum of 10) will be included in the evaluation of each prototype design. The contrast sensitivity function (plotting of contrast thresholds at various spatial frequencies) obtained with filters, myopia control spectacles and soft contact lenses will be compared to the contrast sensitivity function obtained with single vision spectacles and soft contact lenses. Healthy adults aged at least 18 years old will be recruited. Habitual spectacle wearers, experienced and inexperienced contact lens wearers will be recruited.

Acute chest pain is one of most common causes for visits to emergency department (ED) throughout the world. It represents around 5% of all ED visits. Current processes to rule-out acute myocardial infarction (AMI) in the ED are inefficient, costly, and place burden on a system that is already under considerable strain from overcrowding and a lack of resources. Strategies that reduce the number of patients presenting to ED with chest pain and strategies to streamline the assessment of the patients who arrive at ED are urgently required. In this study, we will evaluate a strategy to identify patients who do not need extensive investigation (including serial troponin testing) for possible AMI. We seek to rapidly rule-out AMI using the Abbott cTnI-Nx assay. This point of care assay could ultimately be utilised in the pre-hospital environment (including health clinics or in the primary care setting), or in the ED setting. The goal is to realise a safe assessment method that is patient focussed, avoids hospital presentations, provides value based care, minimises patient risk and reduces ED overcrowding. This is an observational study. Patients will be treated as per standard care. For patients who consent to participate, an additional sample of blood will be taken at the same time as bloods are taken for standard care. This blood will be frozen and stored in the Emergency Department. This blood will later be thawed and analysed using the new Abbott cTnI-Nx assay. The accuracy of this assay for the diagnosis of AMI will be assessed.

Exploratory trial of The Resilience Project (http://theresilienceproject.com.au) which develops and delivers emotionally engaging programs to schools, sports clubs and businesses, and provides them with evidence-based, practical strategies to build resilience. This study is an evaluation of the Resilience Project in the primary school context. We will examine immediate and maintained changes in behaviour of grade 4 to 6 primary school children in relation to use of gratitude, kindness and mindfulness strategies as well as examining changes in children’s personal affect, gratitude, emotional expression and resilience compared to peers who do not receive the Resilience Project Program.

This study aims to assess the feasibility of a low dose, weekly red blood cell (RBC) transfusion for haemoglobin stability in patients with Myelodysplastic syndromes (MDS). Who is it for? You may be eligible for this study if you are an adult with MDS or mixed myeloproliferative/myelodysplastic neoplasm overlap syndrome (MPN/MDS) and who is transfusion dependent (at least two transfusion episodes and at least four units of RBC, in the last 16 weeks) Study details All eligible participants will be randomly allocated to either the usual care Arm A, (continue with their standard treatment) or to the Intervention group, Arm B. The Arm B intervention will involve weekly RBC transfusion using phenotype/genotype matched red blood cells. The number of units per week will be individualised for each patient in the intervention group. All participants involved will experience both treatment arms during the study. Participants will attend weekly transfusions for 6 weeks .The assessment will involve quality of life questionnaires and blood tests. It is possible that maintaining a more stable haemoglobin between transfusions, by transfusing a smaller number of RBCs weekly, may improve quality of life of participants and reduce symptoms. REDDS2 is a collaborative study with the UK National Health Service Blood and Transplant (UK NHSBT) and will inform the design and conduct of a larger trial that will compare red cell transfusion strategies in patients with transfusion-dependent MDS.

This is Part A of a 2-part, Phase 2, Clinical Trial Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Adults with Essential Tremor. Each participant will complete 3 study periods: Screening, Treatment Period (21 or 28 days) and Safety Follow-up.