ANZCTR search results

Following traumatic brain injury, patients frequently enter a state of post-traumatic amnesia and may become agitated. Agitation is threatening to staff and families, impacts access to treatment and is associated with longer hospital stays. Atypical antipsychotics are prevalent in the management of agitation despite a complete lack of well-designed studies underpinning their use in treating agitation in traumatic brain injury. We hypothesise that patients in post-traumatic amnesia, exhibiting agitation who are administered the atypical antipsychotic olanzapine will show lower levels of agitation than those administered placebo.

Iron-deficiency anaemia (IDA) affects approximately 1 in 7 Australian pregnant women, and optimal treatment for improving maternal wellbeing and decreasing blood transfusion remains uncertain. An issue with prior randomised trials of IV versus oral iron is lack of patient and clinician blinding to treatment received, so the primary aim of this study is therefore to determine the feasibility and effectiveness of blinding treatment allocation to IV iron or saline placebo infusion. Participants will be pregnant women with iron deficiency anaemia between 26 weeks and 33 weeks gestation, and will either be given IV iron and placebo capsules or iron capsules and placebo IV. It is expected that using an opaque sleeve covering the syringe and giving set when administering IV iron or saline placebo, followed by matching placebo or active iron oral tablets, respectively, is feasible and effective.

This project tests whether a structured medicines reconciliation service (DCMedsRec) delivered by a community pharmacy soon after hospital discharge may reduce the risk of re-admission within 30 days. This randomised controlled trial will compare the rates of readmission of those receiving the DCMedsRec with others receiving usual care after discharge. Participants receiving the DCMedsRec service will have a structured interview with a pharmacist in a community pharmacy where, using My health record and other sources, the correct medicines and doses will be identified, old medicines and prescriptions may be disposed of, understanding of when and how to take medicines may be confirmed and any questions be answered. It is expected that DCMedsRec will improve medicines use and adherence and reduce the risk of problems that lead to re-admission.

Patients with kidney failure on haemodialysis machines depend on a well-functioning surgically-created enlarged blood vessel in their arm, known as an arterio-venous fistula (AVF). These AVF can develop narrowings, which may progress to complete closure and failure, creating a surgical emergency. Every dialysis, the patient and their nurse check that the fistula is well-functioning by simple physical examination: i.e. can they feel a strong vibration and pulse; can they hear a loud noise with a stethoscope? If concerned, then a patient is referred for a formal Doppler study appointment by a trained technician, using a specialised machine. This study aims to assess whether a simple electronic skin sensor known as an accelerometer (similar to a "FitBit") can detect narrowings inside the AV fistula, by comparing the accelerometer signal waveforms with a concurrent formal Doppler study. We aim to study 60 patients with a range of well- and poorly-functioning AVF's to establish whether the technique is feasible and reliable (i.e. sensitive and specific).

This study will evaluate the safety and efficacy of venetoclax alone or in combination with low-dose cytarabine (LDAC) for Acute Myeloid Leukemia Who is it for? You may be eligible to join this study if you are aged 16 and above and have Acute Myeloid Leukemia in first complete remission. Study details This study is part of the International AML Platform Consortium. Participants in this study will be randomly allocated (by chance) to one of three treatment groups. Participants in one group will receive standard care which is generally observation. Participants in the other groups will receive the drug Venetoclax daily for a total of 24 months or Venetoclax in combination with low-dose cytarabine (LDAC) for a total of 24 months. As part of the study, participants will have blood tests at the start of each cycle (every 28 days) as well as additional blood tests depending on the treatment arm you have been randomised to. These additional blood tests are to monitor the level of neutrophils (type of white blood cell that is important in fighting infection) and platelets (platelets help your blood clot) We hope that the results from this trial will be used to help these new treatments which may be better for people with AML than what is currently available become accessible to the general population at faster than the normal process.

This study will look at a new method for testing muscle function and outcome following knee surgery. The new method uses a bicycle power meter to test muscle power before and after surgery. Ninety patients who are having knee surgery will be tested before and after surgery to look for improvements in muscle power and whether this corresponds with self-reported function. We hypothesise that the bike power meter is a reliable and easy test to look at patient outcome following knee surgery. Results will help surgeons in identifying patients with poor recovery so that more rehabilitation can be provided to improve their surgery outcome.

The Illawarra Shoalhaven Local Health District has twice the national prevalence of chronic kidney disease. Dietary modification plays a key part in preventing progression of kidney disease and managing the complications of end stage kidney disease. Recent research has indicated that inadequate health literacy is common in patients with kidney disease and they have particular problems understanding health information. Local research using a health literacy sensitive question prompt sheet has also found a significant improvement in clinic participation and patient centredness of the consultation. However little is known if this translates into improved patient reported and clinical outcomes. Thus the objectives of this project are to: 1. Evaluate the impact on clinical outcomes of a redesigned health literacy sensitive model of care in the renal dietetic clinics 2. Evaluate the impact of the new model of care on patient reported outcomes 3. Evaluate patient and dietitian satisfaction with the new model of care 4. Make recommendations for ongoing practice

The study aims to evaluate whether, in infants greater than or equal to 32 weeks gestation who require resuscitation at birth, the initiation of breathing either prior to or after umbilical cord clamping affects cerebral blood pressure, blood flow and oxygenation. Large changes in these parameters are potentially injurious and have been seen in animal models following immediate cord clamping. This is a sub-study nested within the Baby-DUCC Physiology Randomised Trial (ACTRN12618000621213). All infants will follow the protocol for the Baby-DUCC Physiology RCT for enrolment, randomisation and follow-up. We present the CHOP study as a sub-study because (a) it addresses a separate, distinct hypothesis using physiological measurements not performed within the BabyDUCC trial, and (b) it has additional inclusion criteria, meaning only a subgroup of infants in the BabyDUCC trial will be eligible. If the infant requires resuscitation after birth, the infant will be randomised to Baby-DUCC (resuscitation prior to umbilical cord clamping) or the control arm (immediate cord clamping and the infant will be moved to the warming bed for resuscitation measures). If the infant is vigorous and does not need resuscitation, the infant will not be randomised and umbilical cord clamping will occur at least 2 minutes after birth, oxytocin administration will occur after umbilical cord clamping. In these vigorous infants, we aim to collect blood pressure, cerebral blood flow and cerebral oxygenation after birth.

The purpose of the study is to investigate whether specific positioning of the preterm baby’s head in the first 72 hours of life will reduce brain bleeds and lead to improved developmental outcomes. The first stage is to determine whether this study is acceptable to parents and whether it is possible to recruit preterm babies in the first four hours of life when the delivery is often an emergency situation. We hypothesize that the study will be acceptable to parents and that it will be possible to recruit babies within the four hour time frame. Babies born less than 29 weeks gestation will receive either usual positioning practice for the first 72 hours or the optimal positioning group. For the usual positioning group, there is currently no standard way to position the preterm baby for the first 72 hours. Babies in the optimal positioning group will be placed on a slightly tilted surface, on their back and with their head in the centre, for 72 hours. The head will be placed on a special pillow designed to mould to the baby’s head and keep the position stable during this time. Brain oxygen levels and presence of brain bleeds will be measured.

This study aims to compare tear film properties including lipid layer thickness, tear osmolarity, tear evaporation rate and noninvasive tear breakup time up to 2 hours after instillation of Systane Complete (test eye drop) versus unpreserved unit dose saline (control), and after 4 weeks of daily use. Participants will be randomly assigned to receive either the test or control eye drop at the first visit. Tear film measurements including the thickness of the oily layer (lipid), stability (noninvasive tear break-up time and tear evaporation rate) and osmolarity (saltiness), and tear collection will be conducted at 1 hour and 2 hours post-eye drop instillation. Participants will be dispensed with this eye drop to be used four times a day until the 4 week follow-up visit. At the 4 week follow-up visit, measurements will be conducted again and the eye drops will be collected. Participants will undergo a 4 week washout period and then be crossed over to receive the alternate eye drop where the same procedures will be repeated as for the first eye drop. Participants will be dispensed with this second eye drop to be used four times a day until the 4 week follow-up visit. At the 4 week follow-up visit, measurements will be conducted again and the eye drops will be collected.