The Baird Institute runs and participates in many clinical trials. We also contribute to the Australian & New Zealand Society of Cardiac & Thoracic Surgery Database through their partnership with Royal Prince Alfred Hospital.
Lisa Turner and Lorna Beattie have over 30 years experience between them.
Lisa has been working in cardiovascular research since 2004. She is the Cardiovascular Research Clinical Nurse Consultant (CNC) at Royal Prince Alfred Hospital (RPAH). Lorna joined The Baird Institute team two years ago and works alongside Lisa as the Clinical Trials Nurse Specialist (CNS). They have over 30 years cardiothoracic and vascular surgery nursing experience between them. Such experience has equipped them with the essential skills required to manage the many and varied Cardiovascular Clinical Trials and associated databases.
COMMUNICATION
One of the most important aspects of Lisa and Lorna’s job is communication, both with and between the patients, staff and medical teams. They are passionate about ensuring patients are well informed about the various research projects relating to their particular surgery. As well. they are given the opportunity to choose to participate in the associated research.
EDUCATION
Education also forms a large part of what Lisa and Lorna do; educating staff on study protocol and ensuring the study teams have a high level of protocol completion and adherence. They also manage patient and staff education in regards to each trial.
CO-ORDINATION
All logistics relating to the trials, are also managed by Lisa and Lorna. Their tasks include managing the screening, recruitment, data collection and ethics reporting for the trials, ensuring all patient follow-up as well as updating the associated databases for the clinical trials conducted through The Baird Institute and RPA.
Along with all of the above, they find time to assist medical students with MD projects through the University of Sydney.
You can support The Baird Institute by making a once-off donation, leaving a bequest, volunteering time or services, or become a partner providing ongoing support.
Our current and completed trials and registries are listed below:
Current Trials
Cardiothoracic Clinical Trials
Name of Project | Project Status |
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VISION - Cardiac Surgery ‘Vascular events in Surgery patients cohort evaluation – Cardiac Surgery’ |
Total recruitment of 15,900 patients across 15 sites. 500 patients recruited at RPAH . Recruitment ceased. In follow up phase until mid 2020. |
COPOC - A prospective randomised placebo controlled double-blinded study to assess the role of colchicine in decreasing myocardial damage post cardiac surgery |
10 patients recruited to date . Aiming for total of 204. |
IRAD ‘International Registry for acute Aortic Disease’ |
3 patients recruited to date Recruitment rate expected to average 10 patients per month from Cardiothoracic, Vascular and Cardiology Departments |
Thoracic aortic surgery database and tissue bank |
Recruiting all aortic surgery patients. Over 150 patients to date |
Molecular Studies in Human Hypertrophic Cardiomyopathy Tissue Bank |
Recruiting all myomectomy surgery patients. Total 15 to date |
Sydney Cardiothoracic Surgeons Database/ ANZSCTS database export |
All cardiac surgery patients Approximately 550 Patients per year |
Virtual Reality Aortic Dissection surgical planning | Awaiting ethics approval |
Frailty assessment in Cardiac surgery | Recruiting all Cardiac surgery patient over 70years of age |
Vascular Surgery Clinical Trials
Name of Project | Project Status |
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ENGAGE “Endurant Stent Graft Natural Selection Global Post Market Registry” |
Total of 12 patients recruited Four patients from the 12 recruited consented to a 6 - 10 year follow up. |
GREAT ‘Global Registry for Endovascular Aortic Treatment’ |
81 Pts recruited at RPAH. Follow up only |
VERNACULAR - The BARD VENOVO TM Venous Stent Study ‘A prospective, Non-randomised, multicentre, single arm study of the treatment of ilio-femoral occlusive disease — An assessment for effectiveness and safety’. |
1 patient recruited at RPAH to add to total of 170 internationally. Last follow up due March 2020 |
Pulse Modulation study The Brain Protection Company Pty Ltd (BPCo) Extravascular Carotid Artery Pulse Modulation Device: First In Human Study | Awaiting ethics approval |
Chrysalis - A Prospective, Multi-Center, Single-Arm Study Assessing the Clinical Use of the CATERPILLAR™ Arterial Embolization Device System for Arterial Embolization in the Peripheral Vasculature | Awaiting ethics approval |
INFINITE-OUS ‘Investigation of femoro-popliteal in situ valve formation with the InterVene System’ |
Recruited total 3 patients since June 2018. 2 completed follow up. 1 in follow up phase |
Completed Trials
Cardiothoracic Clinical Trials
Name of Project | Project Status |
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ATACAS ‘Aspirin and Tranexamic Acid for Coronary Artery Surgery trial’ |
107 patients recruited at RPAH. Study closed out June 2016 |
CORONARY ‘CABG Off or On pump revascularisation study’ |
29 patients in total recruited |
PAINLESS ‘Painbuster length of stay randomised pilot phase trial’ |
10 patients in total recruited |
Warfarin SMART ‘Self-Management of Anticoagulation Research Trial’ |
310 patients recruited |
EVARREST ‘Single- blinded, randomised, controlled, comparative Phase III study evaluating the safety and effectiveness of EVARREST fibrin sealant patch as an adjunct to haemostasis during cardiovascular surgery’ |
Total of 4 patients recruited at RPAH to add to a total of 210 internationally |
International Aortic Arch Surgery Study Group | Data collected from Cardiothoracic surgeons’ database and submitted at the end of 2014 |
Mitroflow Registry ‘Mitroflow Real Life Observational Registry’ |
5 patients recruited Recruitment rate expected to average 2-3 per month |
CLIP ‘A pilot multicentre blinded randomised controlled clinical trial of Cryopreserved platelets vs. conventional LIquid stored Platelets for the management of post-surgical bleeding’ |
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Cardiac Surgery Costing Study ‘A retrospective costing study to estimate the costs of patients undergoing cardiac surgery and selected complications of this surgery’ |
Total number of patient operations at RPAH in 2012 and 2013 |
TRICS III - An international, multi-centre, open-label randomised controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design |
19 patients recruited at RPAH to add to total of 629 recruited in Australia. Follow up complete. Awaiting close out. |
HFSD ‘Heart Failure Surgery Database’ |
Total of 215 patients recruited. Results published 2016 |
Vascular Surgery Clinical Trials
Name of Project | Project Status |
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NOVEL ‘Inferior vena cava, first in Man clinical study’ |
0 patients at RPAH 1 patient at Concord 2 patients at Liverpool. Closed out |
INPACT ‘The INPACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon’ |
Recruited a total of 8 patients. Closed out. Awaiting final report |
SHIELD ‘A multicentre, parallel, blinded, randomised comparison of the safety and efficacy of balloon angioplasty plus intraluminal SBCV to balloon angioplasty alone for treatment of stenosis or occlusion within the femoro-popliteal artery’ |
10 patients recruited. Closed out |
Lutonix BTK ‘Lutonix DCB versus standard balloon angioplasty for treatment of below the knee (BTK) arteries’ |
0 patients recruited at RPAH prior to recruitment cessation. Closed out |
MAJESTIC ‘Stenting of the Superficial FeMorAl and/or Proximal Popliteal Artery ProJEct with BoSTon ScientifIC’s Innova drug eluting stent’ |
Total recruitment - 3 patients Closed out |
EVAR “Prospective evaluation of a model to predict outcomes following EndoVascular AAA repair |
Total patients recruited = 11 Recruitment difficult due to time constraints for Clinical Trials staff. Closed out |