ANZCTR search results

Trail to start at RNSH but plans to become multi-centre involving spinal specialist units in Australia and New Zealand

The study will enroll 230 patients in a randomized evaluation of a new stent delivery system developed for use in small coronary arteries. The study device is designed with a low profile, maneuverable delivery system to reach small, distal lesions. This study is designed to show that the new stents are safe and effective when compared to the comparator, commercially-available stent. Follow-up will occur at 30 days, 6, 8, and 12 month intervals for the first year, then annually for the next four years.

Studying the Fellow Eye Effect of ranibizumab (Lucentis) injections for macular degeneration.

This study is a prospective, observational study to be conducted in the (CRGH) Intensive Care Unit (ICU), over a 2 month period. The aim is to determine the minimum patient room size and optimum room configuration required to provide patient care in the Intensive Care Unit. Nursing staff from which written informed consent has been obtained will have their movements recorded during an 8 hour shift, noting their position in the room or bedspace, along with distances walked and time spent in each location, relative to the configuration of the room. Direct nursing care will not be scrutinized; only the nurse’s location in the bed area will be examined. Measurements for different room and bedspace configurations will then be compared to determine the most efficient room layout in terms of flow and distances walked. Room configurations will then be changed to determine if flow and distances walked, and staff satisfaction changes. A questionnaire will be administered asking consenting staff on their satisfaction ratings for the various room configurations.

The purpose of this study is to examine the post operative efficacy and safety of NRT initiated in patients admitted to hospital for coronary artery bypass surgery. We hypothesise that commencing NRT in the immediate post operative phase will be well tolerated by patients, lead to fewer withdrawal symptoms and greater quit rates at 6 months. This pilot randomised control trial is expected to validate the feasibility of conducting a larger scale multi-centre trial that will generate evidence to support the use of NRT as an inpatient initiated secondary prevention strategy in post-operative bypass patients.

This study is a 6-week, naturalistic open-label evaluation of the efficacy and tolerability of ziprasidone hydrochloride (20mg/day to 80mg/day), in combination with an antidepressant in the treatment of patients with major depressive disorder (MDD), and aims to assess the antidepressant effect of ziprasidone in conjunction with an antidepressant in treating patients who have shown an incomplete or partial response an antidepressant alone.

FAVOURED is a multicentre, randomised controlled trial design. The objectives of this trial are to determine whether the use of the omega-3 fatty acids and to a lesser extent, aspirin, will effectively improve postsurgical outcomes for patients with de novo arterio-venous fistulae (AVF). The study population are patients with stage IV or V chronic kidney disease who require or will require haemodialysis and who are scheduled to undergo creation of an AVF. The primary outcome is AVF Access Failure, which is a composite of Thrombosis, AVF Abandonment, and Cannulation Failure during the Cannulation Assessment Period. Secondary outcomes include AVF access failure according to strata of aspirin use, safety and adverse events of omega-3 fatty acids and aspirin alone or in combination, catheter use, and rescue interventions.

Study Title An open label, phase IV clinical trial examining the efficacy of Prothrombinex alone versus Prothrombinex combined with fresh frozen plasma in patients who require Warfarin reversal Trial Objectives The primary aim of this study is to determine whether Prothrombinex alone is adequate and effective in the reversal of the anticoagulant activity of Warfarin. Number of patients 40 Inclusion Criteria 1. Patients who are on Warfarin therapy with an asymptomatic INR >9 where the treating clinician wishes to reverse the effects of the drug 2. Any clinically significant bleeding where Warfarin induced coagulopathy is considered a contributing factor and an INR of >2.5 where Warfarin reversal is considered important by the clinician 3. Pre surgery if INR >2.5 on the day of surgery and the clinician requires reversal of the effects of Warfarin 4. Patient is = 18 years of age. 5. Patients that are able to understand and apply with study protocol requirements and instructions and intends to complete the study as planned.6. Patient signs and dates written informed consent. Exclusion Criteria 1. Active bleeding requiring blood transfusion. 2. Patients with a known allergy to prothrombin complex concentrates or fresh frozen plasma. 3. Participation in another pharmacotherapeutic study within 30 days. Objective criteria for study entry 1. Asymptomatic INR > 9 where there is a high risk of bleeding 2. Any clinically significant bleeding where Warfarin induced coagulopathy is considered a contributing factor and an INR >2.5 where Warfarin reversal is considered important by the clinician 3. Pre surgery if INR > 2.5 on day of surgery and the clinician requires reversal of the effects of Warfarin Outcomes The primary outcome is the rapid reversal of Warfarin as indicated by the correction of the INR to < 2. Safety outcomes: Allergic reaction to Prothrombinex, the development of a complicating thrombosis (venous or arterial) and the presentation of clinically overt bleeding

This project aims to determine the dose-response effect of low doses of long chain omega-3 polyunsaturated fatty acids on plasma triglyceride levels in pre-menopausal women with mildly elevated triglycerides. The dose-response effect on plasma lipoprotein levels and particle size, as well as omega-3 levels in various blood samples (plasma, erythrocytes, whole blood from fingertip) will also be investigated.

Paracetamol is first-line pain management for osteoarthrits and this study is designed to investigate patient preference for sustained release paracetamol given 3xdaily compared with standard paracetamol tablet given 4xdaily.