ANZCTR search results

We intend to undertake this research project on ROTEM®, which is a rapid and specific blood clotting test which has been recently introduced to analyse clotting. This is a rapid test in that results can be obtained within 10 minutes, compared with 30 to 60 minutes for the current standard clotting test. It is specific in that it further defines parameters to assist in deciding what blood products need to be given in the event of bleeding. We will also analyse platelet function using a test called Multiplate®. The purpose of this study is to better understand the type and extent of clotting issues that are potentially seen with the pregnancy-related condition known as pre-eclampsia. You will not receive any direct benefit from participating in this study, but the knowledge gained from this research will help us to improve the management of major bleeding in pregnant patients. If a patient develops pre-eclampsia (uncommon condition) throughout the course of their pregnancy and if they agree to participate, then we will obtain a 7.5mL blood sample either through their IV drip or cannula when it is placed, or when they have blood tests done. This blood sample will be used to process for Multiplate® results, ROTEM® clotting test and the standard clotting test. If the patient has further routine blood tests performed, we will perform matched samples until the pre-eclampsia resolves. If a patient's pregnancy is uncomplicated and if they do not require an IV drip or any blood tests during their labour, then they will not be included in the study. As a substudy, we intend to recruit 20 women undergoing an elective Caesarean, who have experienced uncomplicated pregnancies and have no history of coagulation disorders, to establish a normal range against which the results of our main study cohort will be compared.

Xerostomia or dry mouth is a major problem that many people experience, especially those who have received radiotherapy for the treatment of head and neck cancer and it accompanies other diseases such as Sjögren syndrome. Saliva plays many vital roles in our daily life and people with reduced saliva production can experience a variety of health problems. Pilocarpine is a medication that stimulates the nerves supplying the salivary glands. This stimulates the production of your own saliva. The effect lasts for about three hours, and so it is usually taken three times daily. Pilocarpine is usually taken before a meal to produce more saliva in time for eating. Pilocarpine is only available as eye drops to treat glaucoma in Australia, but tablets are available for treating dry mouth in many countries around the world. This trial investigates pilocarpine orally dissolving tablets (ODTs), which are little tablets that dissolve rapidly in the mouth and can be compounded in pharmacies. This trial will provide information about whether pilocarpine ODTs are effective in treating dry mouth, and this information will help to improve management of dry mouth in Australia. A series of single patient (N-of-1) trials of 5 mg pilocarpine ODTs (intervention) vs placebo ODTs (control) will be run, in people suffering with xerostomia, with a population estimate of the benefit following the combination of multiple SPTs. Participants will complete 18 days of treatment, consisting of 3 cycles. Each cycle contains two periods: 3 days treatment, 3 days placebo. The first day of each period is considered to be the washout and data collected will not be included in analysis. The order of treatment and placebo will be randomly allocated for each cycle. Treatment allocation will be blinded to the participant and the Primary Investigator.

The objective of this study is to evaluate the efficacy and safety of donepezil transdermal patch comparing to donepezil oral tablet (Aricept) in patients with mild to moderate Alzheimer’s disease.

This study aims to assess feasibility of conducting a randomised efficacy trial to compare two different methods of anaesthesia in patients undergoing major cancer surgery. Who is it for? You may be eligible to join this study if you are aged 18 years and over and are scheduled to undergo major cancer surgery expecting to last two or more hours. Study details Study participants will be allocated by chance to one of the two groups. Group 1 - Inhaled anaesthesia, Group 2 - Anaesthesia administered via a cannula into a vein in the arm. This study will inform conduct of a large efficacy trial which will aim to provide insight into the mechanisms by which anaesthetics potentially drive cancer progression with the ultimate goal of developing novel biomarkers and strategies to limit the impact of anaesthetics on cancer progression.

Complex medication regimens are prevalent in residential aged care facilities (RACFs), can be burdensome for residents and are costly in terms of nursing time. The aim of this study is to investigate application of a structured process to simplify medication administration for residents of aged care facilities. We hypothesise this may reduce the total number of medication administration times and decrease time spent administering medications, and may improve clinical outcomes for residents. SImplification of Medications Prescribed to Long tErm care Residents (SIMPLER) is a non-blinded, matched-pair, cluster randomised controlled trial of a single multidisciplinary intervention to simplify medication regimens in RACFs. Research nurses will recruit English-speaking, permanent residents from 8 South Australian RACFs. Medications taken by residents in the intervention arm will be assessed once using a structured tool to identify opportunities to reduce medication regimen complexity (e.g. by administering all medications at the same time, or through the use of longer-acting or combination formulations). Residents in the comparison group will receive routine care. Participants will be followed for up to 3 years after study entry. The primary outcome will be the total number of charted medication administration times at four months after study entry. Secondary outcomes will include time spent administering medications, medication incidents, resident satisfaction, quality of life, falls, hospitalisation and mortality. Individual-level analyses that account for clustering will be undertaken to determine the impact of the intervention on the study outcomes. Study results will be disseminated via conference presentations and manuscripts submitted to peer reviewed journals.

This study aims to evaluate the effects of Nivolumab in Combination with Ipilimumab on biochemical and physiologic functions in Subjects with Advanced or Metastatic Solid Tumors. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a histologically or cytologically confirmed, metastatic or locally advanced solid tumor for which no standard therapy exists or standard therapy has failed. Study details Approximately 21 eligible patients with advanced or metastatic solid tumors will be enrolled into two cohorts. In the first cohort, nine (9) subjects will receive 1mg/kg of ipilimumab every 6 weeks and Nivolumab 3mg/kg every 2 weeks until disease progression or discontinuation due to toxicity or a maximum of 12 weeks. The second cohort of twelve (12) subjects will receive 0.3mg/kg of ipilimumab every 6 weeks and Nivolumab 3mg/kg dosed every 2 weeks until disease progression or discontinuation due to toxicity or a maximum of 12 weeks. The investigators seek to identify/confirm circulating pharmacodynamic biomarkers that correlate with immune activation.

Despite best medical intervention, people with Parkinson’s disease (PD) show a steady decline in physical functioning over time. Research shows that exercise is beneficial to improve and maintain physical function and physical activity in people with PD but a challenge is to maintain this over time. This project aims to assist people with PD to improve their physical activity levels and importantly maintain them, by trialling a new intervention of physiotherapy group sessions that combine exercise, self-monitoring with armbands and the self-management skills needed to improve their physical activity levels.

The aims of this project are to: a. investigate whether the serum composition of post-menopausal women can be altered with 4 weeks of fish oil supplementation and an acute bout of resistance exercise b. Can changes to inflammatory markers in serum alter the activity of muscle cells grown in-vitro Proposal research design: The study is a randomized cross-over design study with a 4 week washout period between groups: Fish Oil group. Participants will be required to ingest 4 fish oil capsules (6g/d containing 2.16g of EPA and 1.42g of DHA) PUFA daily for 4 weeks. This dose has been selected as it is the dosage range recommended by the Australian Heart Foundation for lowering plasma triglyceride concentrations in hypertriglyceridemic subjects and has therefore previously been shown to be physiologically relevant in human subjects. Placebo group. Participants will be required to ingest equivalent amounts of coconut oil (6g/d) for 4 weeks. Coconut oil has been selected as it has been used as a control in other studies involving fish oil. Resistance Exercise. The acute exercise intervention will consist of both upper and lower body exercises including: the leg press, leg extensions, the bench press and dumbbell side lateral raises. The duration of the exercise session, including adequate warm-ups, will be ~60 minutes.

REPAIR is a study investigating the role of regional anaesthesia (RA) for reducing pain experienced during dressing change for patients who require split skin grafting after suffering burn injuries to the upper limbs. There are approximately 50,000 burn related hospital admissions per annum in Australia at an economic cost of $230m. This patient cohort may experience neuropathic or nerve pain that is notoriously difficult to treat. This trial will compare current pain practice with the use of RA in patients who have suffered burns and require dressing changes on the ward post split-skin grafting procedures. This study aims to redefine the way clinicians treat burn pain, and to lay the ground work for further investigation into RA and optimization of care for patients with burn injuries. Aim: To assess the effectiveness of regional anaesthesia as an intervention for burn pain associated with change of dressings and removal of staples after split skin grafting procedures to the upper limbs. Objectives: 1. To compare and contrast the outcomes of two patient cohorts receiving removal of staples and dressing change after upper limb split skin grafting including: a. Control group receiving standard opioid intervention as per treating team. b. Cohort receiving a single dose nerve block to upper limb grafting site. Methods Prospective, randomised clinical trial. Following institutional ethical approval, 20 participants will be sourced from the Royal Brisbane and Women’s Hospital acute in-patient burns unit. Written, informed consent will be obtained before patients are enrolled in the study. Patients will only be enrolled if they meet the inclusion criteria, and consent to the study. This study population of 20 patients will be divided into two groups (10 patients in each) with a control and interventional group. Once informed consent is obtained, participants will be randomised into two groups using a random number generator and sealed envelopes.Group one (I) will receive standard opioid intervention as per their treating team. Group two (II) will receive will receive standard opioid intervention with the addition of an ultrasound guided single-shot axillary brachial plexus block using 0.375% ropivacaine of 20-30mls. All patients will be charted post-procedural pain relief and antiemetics as per their treating team, and the addition of regional blockade will not affect availability of pain relief in any way. All blocks will take place in the designated anaesthetic block room prior to dressing change procedure. Blocks will be placed by qualified and experienced anaesthetic fellows and consultants under direct ultrasound guidance, employing aseptic technique, and according to standard practice. Patients will be followed up by a study member and data will be collected pertaining to numeric pain scores and opioid requirements daily for 7 days post-procedure or until discharge from hospital if it occurs sooner.

RELIEVE is a study investigating the role of regional anaesthesia (RA) for reducing pain for patients who require split skin grafting after suffering burn injuries. There are approximately 50,000 burn related hospital admissions per annum in Australia at an economic cost of $230m. This patient cohort may experience neuropathic or nerve pain that is notoriously difficult to treat. This trial will compare current pain practice with the use of RA in patients who have suffered burns and require split skin grafting. This study aims to redefine the way clinicians treat burn pain, and to lay the ground work for further investigation into RA and optimization of care for patients with burn injuries. Aim: To assess the effectiveness of regional anaesthesia as an intervention for treating pain resulting from anterior thigh split skin graft donor sites in patients undergoing burn injury treatment. Objectives: To compare and contrast the outcomes of two patient cohorts receiving split skin grafts for burn related injuries: a. Control group receiving standard intervention for harvest of donor site skin from the anterior thigh as per treating team. b. Cohort receiving a single dose fascia iliaca plane block (FIPB) (incorporating blockade of the femoral nerve and lateral femoral cutaneous nerve of the thigh). Methods Prospective, randomised clinical trial. Following institutional ethical approval, 20 participants will be sourced from the Royal Brisbane and Women’s Hospital acute in-patient burns unit. Written, informed consent will be obtained before patients are enrolled in the study. Patients will only be enrolled if they meet the inclusion criteria, and consent to the study. This study population of 20 patients will be divided into two groups (10 patients in each) with a control and interventional group. Once informed consent is obtained, participants will be randomised into two groups using a random number generator and sealed envelopes. Group one (I) will receive standard opioid administration and surgeon local anaesthetic infiltration as per their treating team. Group two (II) will receive an ultrasound guided single-shot fascia iliaca plane block (FIPB) of 0.375% ropivacaine of 20-30mls to provide donor site analgesia on the day of surgery. All blocks will take place in the designated anaesthetic block room prior to general anaesthetic for split skin graft harvesting. Blocks will be placed by qualified and experienced anaesthetic fellows and consultants under direct ultrasound guidance, employing aseptic technique, and according to standard practice. Patients will be followed up by a study member and data will be collected pertaining to numeric pain scores and opioid requirements daily for 7 days post-procedure or until discharge from hospital if it occurs sooner.