ANZCTR search results

Analysis of 175 patients (median age 65 range 53-77 years) who underwent orthopaedic surgery at the Launceston General Hospital (LGH) during the last 4 months revealed that approximately 25-30% of the patients had mild anaemia (Hb>100 g/L and below <140 for males and 120 for females). Unfortunately there is no data regarding haematinics deficiency or amount of blood transfusion in this cohort of patients. Hence the importance of this trial to study all of these factors in Tasmanian patients and provide a solution to this problem. To address this problem and improve health services at LGH, we are aiming to study patients with mild anaemia only (Hb>90 g/L) and have no specific cause for anaemia and randomise them between administration of oral iron therapy or intravenously (i.v.) As common practice we have performed 78 iron infusions at a single centre (Holman Clinic) in 2005 and 48 infusions in the last 6 months without a record of a single case of intolerability. All patients who received i.v. iron infusion preceded by premedications with antihistamine and low dose steroids, did not experience any side effects. In summary, this study is dealing with an important problem which is preoperative mild anaemia in orthopaedic patients which is usually significantly increased in this cohort of patients. Also, we are aiming to overcome exposing this group of patients (with low preoperative Hb) to unnecessary blood transfusion with subsequent hazards/complications of blood transfusion and complications of anaemia. Primary objectives: 1. To study the effect of haematinic replacement on peri-operative mild anaemia (Hb>90 g/L) in order to optimise preoperative haemoglobin level in patients who undergoing elective orthopaedic surgery. 2. To reduce pre, peri and postoperative exposure to allogeneic blood transfusion and hence to avoid its subsequent complications/hazards. Bearing in mind that the current shortage of blood supply might lead to cancellation of this type of elective surgery. Secondary objectives of the study: 1. As a pilot study of the effect of vitamin B12 on erythropoeisis in those patients, who are receiving iron therapy 2. To assess patient outcome, recovery and quality of life 3. To assess the benefits in minimising length of hospital stay 4. To obtain additional information on the transfusion needs of non-anaemic patients, and the relationship to their iron status.

To study the Quality of Life Assessed by the European Organization of Reseach and Treatment of Cancer (EORTC) disease spesific module and disease free survival and overall survival in patients with mulitple myeloma after Tandem Autologous Stem Cell Transplantation (ASCT) Assessment of patient: 1. Age and sex. 2. Stage of disease initially and at time of recruitment (according to the World Health Organization (WHO) Myeloma Staging System). 3. Type of myeloma disease (M protein): Paraprotein quantification, Serum free light chains, Bence Jones Protein quantification. 4. Skeletal Survey: documentation of all lytic lesions at time of diagnosis and recruitment. 5. Liver and kidney function, C-reactive protein (CRP), Erythrocyte sedmintation rate (ESR), Beta 2 microglobulin (B2M), serum Calcium will be determined at time of the study, and if possible, traced from time of diagnosis. 6. Bone marrow study will be traced from time of diagnosis and relapse when it is possible with documentation of plasma cell content in the bone marrow. 7. Cytogenetic studies will be offered for the patients during routine marrow test to determine the cytogenetic risk factors including 13q- and translocation t(4,14) and its correlation with disease outcome as per our registered trial ACTRN12609000594224. 8. All previous treatments received and response to each treatment should be documented. Monitoring and assessment of quality of life and pain: Quality of life assessment and symptoms, in particular pain, will be assessed quarterly (after initial assessment) and at the end of the study as per the EORTC quality of life questionnaire (QLQ-C30) with disease specific module. In the case of patient willingness to take part in the study, a written consent will be completed, after which the patient will be formally enrolled in the study. Follow-up will be conducted every 8-12 weeks for the first 24 months after the second stem cell transplant. A clinical assessment form will be filled out at each visit. A full patient profile will be obtained including such detail as medical and drug history, risk factors for multiple myeloma. The patient demographic and physical detail (weight, height etc) will be also measured and recorded. Other routine data and laboratory investigations including kidney and liver function will be recorded. All patients will be counselled that if they decide to withdraw from the study at any time, this will in no way affect their care or procedure at the treatment centre.

This study aims at evaluating the prognostic value of chromosome 13 deletions as well as t(4,14) as detected by the FISH/qPCR techniques in multiple myeloma patients. The impact of these abnormalities in the context of high-dose therapy (HDT) or conventional therapy will help to identify those patients who would maximally benefit from HDT and those who would be refractory to HDT and might benefit from other therapeutic options. Furthermore, it would be of great value for determining the prognosis of the disease to study the prognostic factors of myeloma, including -13q and t(4;14), at the time of diagnosis, prior to and after transplantation, and at the time of relapse, with special emphasis on the outcome of patients who underwent HDT. Moreover, these data might supply valuable guidance regarding identification and cloning of a MM-tumour suppressor gene.

The EpiNo trial is trialing the use of a commercially available intravaginal balloon device in order to determine whether this device reduces the risk of major pelvic floor trauma at vaginal delivery.

Therapeutic transplantation of haematopoietic stem cells (HSCs) is an increasing area of interest in medicine. In autologous stem cell transplantation, there is the ability to harvest stem cells soon after chemotherapeutic treatment, and then cryo-preserve and store such cells for stem cell transplantation at a later date. CD34 is the typical cell marker used to identify HSCs for transplantation. There exist certain limitations to CD34+ HSCs which include its expression on cells not capable engraftment, and also on acute leukaemic cells. CD133 is an alternative cell surface marker on HSCs which could prove useful in identifying cells for transplantation. Preliminary research suggests that CD133 is a more primitive marker, which is expressed by early progenitor cell line, and it has the additional advantage of not being expressed on acute leukaemic cells. The Launceston General Hospital is the site for stem cell harvest for the North and North-West of Tasmania. Annually, approximately 20-30 patients undergo stem cell harvest with the aim of later transplantation. This project is a pilot study to evaluate the value of CD133 in addition to the usual marker CD34+ as a cell marker for HSCs while using the current protocol for stem cell harvest. There is currently little data on the validity of CD133 as a HSC marker, and this project, as a part of Master degree at the School of Human Life Sciences at the University of Tasmania, aims to add to the current data and potentially identify the role of CD133 as HSC marker. We are aiming to study 30-50 patients with different haematological malignancies that require stem cell harvest with subsequent stem cell transplantation during a period of 24 months at the LGH, Tasmania. Current numbers of autologous stem cell harvest at a single centre; the LGH are varied between 20 and 30 episodes per year. Our current autologous stem cell harvest-protocol for patients with malignant haematological disorders is employing mobilisation chemotherapy with cyclophosphamide 5g/m2 and subsequent administration of granulocyte colony stimulating factor (G-CSF) subcutaneously daily at a dose of 10mcg/kg body weight (BW) until harvesting sufficient stem cells per transplant defined as at least 2x106 stem cells/Kg BW. We will start to measure both CD 34+ and CD 133+ daily using the flow cytometr (Becton-Dickenson) when the white cell count (WCC) recovers above 1.0/nL post chemotherapy and until the time of stem cell harvest at the Holman Clinic. Thereafter we will measure both markers according to manufacturer reccomendations (with commercially available CD34 and CD133 kits) in the harvest product for each patient. Correlation between the amount of harvested CD 34+/CD133+ cells and patient engraftment will be documented for each patient. Using commercially available kits, we are proposing to study the progenitors cells which express CD133 antigen by flow cytometry technique according to the manufacturer recommendations as a part of the usual daily measurement of CD34+ cells. There is no additional sample will be required from patients and hence this will not expose the participants to any extra burden. Also we are proposing to measure CD133+ in addition to CD34+ stem cells in the stem cell product garnered by the stem cell harvest. Using flow cytometry to study stem cell characteristics in the leukaphoresis product will provide useful information regarding engraftment kinetics. Platelets engraftment is defined as reaching platelet count>20/nL without substitution, while neutrophil engraftment is defined as reaching neutrophil count above>0.5/nL.

The study is the first to investigate whether self selected music, played during the initial radiotherapy session, alters patients’ anxiety states. It uses a randomized, single centre, unblinded design with the outcome measure being the change in state-trait anxiety inventory (STAI) state anxiety score from baseline to post radiotherapy. The study sample size has adequate power to detect a clinically meaningful difference in anxiety between the two treatment arms should treatment be effective. Qualitative data collected after participants' radiotherapy treatments will also elucidate subjective experiences amongst participants receiving radiotherapy with music or standard care radiotherapy.

The study will investigate the association between sleep-disordered breathing during pregnancy and foetal growth and well-being. It is hypothesised that Obstructive Sleep Apnoea is detrimental to foetal health (acute foetal compromise as evidenced by abnormal cardiotocography (foetal heart rate monitoring) during sleep and impaired foetal growth in late pregnancy).

The study aims to determine whether vitamin D deficiency is associated with increased cardiovascular risk and whether that risk is reversed by vitamin D replacement.

Pain treatment is vital part of postoperative care as a delayed or insufficient treatment of pain can significantly impair a patients outcome. Prerequisite of successfull treatment is the assessment of pain. This can be difficult in younger children who lack the ability to communicate their pain. Aim of this observational trial is to define the relationship between physiological parameters such as blood pressure, heart rate, skin conductance parameters and heart rate variability and acute postoperative pain. At the same time, we aim to prospectively test cut-off values for the skin conductance parameter "number of skin conductance fluctuations per second" (NFSC) obtained in an earlier study to distinguish between no/mild and moderate/severe pain. 150 peadiatric patients aged 1-16 after elective surgery will be included and the relationship between above mentioned parameters and acute postoperative pain (measured on standard pain scales during the patients stay in the recovery room) will be examined.

The purpose of this study is to investigate the difference in torsion in primary position (head straight, looking straight ahead) and compare it to measurements in 15 and 30 degrees in downgaze (head straight, eyes looking downwards). It is hypothesised that torsion will increase in downgaze, especially in cases of bilateral superior oblique palsy. Therefore, we hope to establish an amount of torsion that differentiates bilateral and unilateral superior oblique palsy. This will help clinicians plan treatment and hopes to avoid cases of "masked" superior oblique palsy (where after surgery for a unilateral superior oblique palsy, a superior oblique palsy is uncovered in the other eye).