ANZCTR search results

Hereditary Angiodema (HAE) is a rare disease caused by low levels of C1 serine protease inhibitor in the body. Deficiencies in this protein leads to increased activation of inflammatory pathways which can cause swelling, severe abdominal pain and airway obstruction that can be life threatening. ATN-249 is a potential once a day oral treatment for HAE. The purpose of this research study is to test the safety and tolerability of ATN-249 as well as the pharmacokinetics and pharmacodynamics of the study drug. The study is open to healthy male volunteers and the research goals are: - Does the drug have any side-effects and is it well tolerated when given as a single dose? - How much of the drug gets into the blood stream, and how long does the body take to get rid of it? - What effect does food have on the PK profile of the study drug? This study will look at how the human body uses ATN-249 at different dose levels with and without food. The effects of the drug will be studied. This is a double-blind, randomised and placebo-controlled and consists of two parts. Part A will look at the effects of a single dose of the study drug given as 1 dose and Part B will look at the effects of a single dose of the study drug given as 2 doses 12 hours apart.

This trial protocol has been endorsed by the ANZCA Clinical Trials Network. We aim to conduct a multicentre, randomised controlled trial of the efficacy and safety of peppermint- flavoured chewing gum to treat postoperative nausea and vomiting (PONV) in the post-anaesthesia care unit (PACU). We will test the primary hypothesis that chewing gum is non-inferior to ondansetron in achieving complete cessation of nausea, retching and vomiting within 2 h of administration, with no recurrence between cessation and 2 h after administration, and no rescue medication between administration and 2 h after administration (i.e. complete response) in female patients aged 12 years and older with nausea, retching and/or vomiting in the PACU after volatile anaesthetic-based general anaesthesia for breast or laparoscopic surgery. Chewing gum is a simple and inexpensive drug-free treatment for the common, costly and distressing problem of PONV. This study has the potential to significantly improve clinical and economic outcomes for millions of patients and health services in high-, middle- and low-income nations worldwide.

This is an open label study of patients with macular oedema, secondary to diabetic retinopathy who are naïve or have minimal exposure to intravitreal anti- vascular endothelial growth factor (VEGF) therapy. The study will assess the effectiveness of a treat and extend regimen of intravitreal Aflibercept (Eylea) in a clinical setting,

This research project is designed to test the safety, tolerability, the effect on movement and pharmacokinetics (how the body processes the study drug) of INP103. INP103 is a drug-device combination product; the drug is L-dopa (levo-dopamine); the device is the I231 Precision Olfactory Delivery (POD) device, which is a novel nasal (nose) spray. This study will measure the results of administration of L-dopa given by the intra-nasal POD device, against the effect of placebo, also given by the intra-nasal POD device. Participants will be given either L-dopa or placebo to determine how effective the new POD device is at delivering the drug to the body.

Emergency Departments in NSW and across Australia continue to face significant challenges relating to overcrowding and access block. These conditions are projected to deteriorate as the number of patients needing emergency treatment, particularly older patients with cardiovascular presentations (chest pain, shortness of breath) and other chronic medical conditions, continue to increase. The people of NSW urgently need innovative solutions, as part of an overall strategy, to improve ED patient flow and access to timely care. Decisions regarding hospital admission or discharge are critical to ED functioning, meeting patient expectations, resource management and patient outcomes. These disposition decisions are typically made after a series of nursing and medical assessments, which for many patients take several hours. This can cause patient dissatisfaction and increased anxiety, especially for patients with chronic conditions The aim of this project is to facilitate earlier disposition decision making in patients’ journeys through the hospital system in order to reduce ED length of stay, allow patients to access acute medical care earlier and ultimately reduce the burden of ED overcrowding. We propose to implement and evaluate the clinical effectiveness of a novel disposition decision support tool based on State-wide data analysis. It is designed to be used by emergency clinicians at the earliest time possible in patient care to significantly improve timeliness and appropriateness of disposition decision making. The project will be undertaken as a pragmatic randomised control trial and process evaluation at facilities within Sydney Local Health District, with a plan to implement across other LHDs in collaboration with the NSW Agency for Clinical Innovation and E-Health NSW. It is one of twelve priority areas for action identified by the current New South Wales Government (https://www.nsw.gov.au/premiers-priorities ) and most importantly, will bring data analytics to the bedside in order to improve ED patient processes and outcomes for the future.

The objective of the study is to determine whether tourniquet use during total knee replacement results in superior intra-operative and post-operative outcomes when compared to not using a tourniquet. All participants will be undergoing total knee replacement for advanced osteoarthritis. Participants will be followed up for one year following surgery. Outcomes include knee extension strength, pain and analgesia requirements, self-reported physical function and quality of life, blood loss and replacement, surgeon satisfaction with the intra-operative visual field, operation and anaesthetic time, tourniquet inflation time, complications including revision surgery, cement mantle quality, patient satisfaction, and hospital length of stay.

The primary objective of this RCT is to compare the short-term (8-weeks) effects of a protocol developed by a commercial organisation which combines commercially pre-prepared meals and structured exercise programme with a programme which include standard dietary guidelines with a structured exercise programme on body composition changes (body weight and fat mass). The secondary objective is to examine biological factors (fitness and blood profile) and psychosocial well-being and facilitators and barriers to completing the intervention programme and its acceptability.

Background: There is plenty of literature available regarding the harmful effects of smoking and the potentially significant positive influence of counselling in the pre-operative period on long-term cessation. There are, however, few studies and guidelines about this in the Australian healthcare system. Hypothesis and aim: Our study hypothesis is that counselling regarding the advantages of quitting smoking in the pre-admission clinic leads to long-term smoking cessation, and we aim to prove this through our study among smokers undergoing elective surgery in the Armadale Health Service. Methods: We will conduct a non-randomised controlled trial among smokers having elective surgery in the Armadale hospital from April 2018 onwards, aiming to recruit 247 smokers who received pre-operative advice to stop smoking, constituting the intervention group, and 247 who underwent surgery prior to April 2018, who did not receive such advice, comprising the control group, by means of telephone interviews. The primary outcome will be the quitting status 6 months after surgery. The data would be analysed using unpaired chi-squared test. This study will be able to detect a significant increase in quit rates after counselling with a type I error of 0.05 and a power of 0.8. Significance: If we are able to show a significant improvement in long-term quit rates after pre-operative counselling, we can create guidelines for our hospital and provide evidence for the Australian health system to make the provision of tailored advice and support to stop smoking during routine pre-anaesthetic check-ups a necessary standard of care. This could be the beginning of an intensive “Quit Smoking Before Surgery” campaign. As a large proportion of smokers would present themselves for surgery at some point in their lives, this might be an easy and highly effective method of reducing the prevalence of this harmful habit in our society.

Children presenting to the emergency department with lacerations is very common. We wish to conduct a study that compares two types of stitching techniques (called 'deep dermal suturing' and 'simple interrupted suturing'). Both of these methods are commonly used, however it has not been concluded which technique is better for healing lacerations in the child population. Participants will be assigned to receive either the deep dermal technique or the simple interrupted technique to close their wound. Participants (or their family or guardians) will not be aware of which group they are in. After the stitching is complete, the wound will be bandaged for up to 7 days, and participants will be instructed not to remove the bandage or inspect the wound at any time. Participants will be asked to return to an assigned clinic 3 days, 7 days and 3 months after the initial presentation. Here, wounds will be assessed by staff and stitches may be removed (this may require anaesthesia or sedation). If the wounds are found to have incomplete wound closure or dehiscence, a second suture will be administer and patients will be asked to come back at day 14 for reassessment. Three months later, the scar from the wound will be photographed, and medical staff will be asked to rate the appearance of the scar. We aim to determine which of these two methods are superior, considering the economic cost, infection rates, cosmetic outcome and time for wound closure. With these factors in consideration, we hypothesise that there is a clinically significant difference between the deep dermal absorbable and simple interrupted nonabsorbable sutures.

The primary aim of this study is to compare the success rates of the new POP pessary compared to the conventional PVC ring pessary. Treatment success will be defined as retention of the pessary at 6 months follow-up. The secondary objectives are to evaluate subjects’ ability to perform self-care during pessary use, subjects’ satisfaction with pessary treatment and complications. Compared to surgery, vaginal pessaries have been the subjects of minimal scientific research. In particular, long-term vaginal pessary usage has been poorly studied.Whilst there are various shaped vaginal pessaries available it is standard clinical practice is to use a polyvinyl chloride (PVC) ring pessary that is usually changed or replaced every 6 months. With currently available pessaries, the overall retention rate of vaginal pessaries is low, due to discomfort, inconvenience, vaginal discharge or dislodgement. The failure rate (i.e. discontinuation with pessary usage) vary from 27% to 74%. The limited efficacy of currently available vaginal pessaries is well recognized. In our unit we have conducted two studies relevant to vaginal pessary use. They were the vaginal dimensions based on vaginal casts taken from 60 women with pelvic organ prolapse and also biofilm formation on vaginal pessaries after 6 months of use. In order to reduce discharge associated with pessary use patients can be instructed in ‘self-care’ of their pessary by learning how to remove, clean and replace their pessary. However, some women find if difficult to remove and replace traditional PVC ring pessaries. Based on the results of these studies, we have developed a more anatomically shaped pessary. The additional ‘fold points’ in the rim of the pessary and a loop at the caudal end of the new pessary were incorporated into the design to enhance patients’ self-care during pessary use. The ‘fold points’ in the new pessary will make it more flexible (relative to the PVC pessary) during removal and replacement. A loop attached to the caudal aspect of the new pessary will facilitate removal of the pessary by the patient. With the above features, we have hypothesized that the new POP pessary will be at least 30% more successful than the conventional PVC ring pessary.