I hold a current NIDA Clinical Trials Network Good Clinical Practice Certificate
ORCID ID: orcid.org/0009-0005-5048-8221
1. 2025 proposed -ExPediTe-CABG PROPOSED RANDOMISED CONTROL TRIAL : Early Platelet Testing to Expedite urgent cardiac surgery and determine safety and cost effectiveness
(see presentations)
Four-year multicentre, randomized trial in urgent CABG inpatients evaluating whether early platelet testing, using a Multiplate guided algorithm, is non-inferior to waiting the prescribed washout period usually established for the platelet inhibitor given.
Primary endpoint blood loss for 24 hours from skin incision and secondary endpoints include transfusion and QOL at 6 months.
Funding Agency: POW FOUNDATION and potentially RES-ON SESLHD application to be announced late 2025, will apply for NHMRC, MRFF and Heart Foundation Grants.
Title: ExPediTe-CABG proposed RCT using Early Platelet Testing to Expedite urgent cardiac surgery and determine safety and cost effectiveness
Investigators: Catherine Downs, Prof Jason Abbott (clinical trialist PhD), Dr Akshat Saxena (cardiac surgeon PhD), Dr Mitch Nolan, Dr Aine Duggan and Dr Lisa Clarke (Haematology)
My Role: Principal Investigator currently developing the protocol and redcap database
Budget: $10,000 acquired from POW Foundation, $40,000 application to assist with grant submission as need $606,000 to proceed commencing recruitment 2027
ClinicalTrials.ANZCTR Identifier-in future
(see also presentation to ANZCA clinical trials network Adelaide August 2025)
2. 2019 - 2029 : ROTEM 2019/ETH PID12980 (Regis)
Funding Agency: POW Foundation 2023 and 2024 and UNSW seed grant 2025
Title: A prospective audit: monitoring the use of ROTEM for transfusion in critically bleeding
patients on Randwick Campus.
Investigators: Catherine Downs, Ass Profs David Sandeman, Leonie Watterson and Rob Turner
My Role: Co-ordinating Principal Investigator- creation of database and developing ongoing projects investigating and presenting transfusion practices across the campus
Budget: 2023 $600 for creation of an advanced educational Video for students and JMOs.
2024 $1000 commenced creating a database for ROTEM data analysis
2025 $5000 UNSW SEED grant used to complete the database for the ILP student projects
Impact: has been local quality improvement, one book chapter outlining our results in Australasian Anaesthesia, and 8 poster presentation.
AUSTRALASIAN ANAESTHESIA 2017 page 77: https://www.anzca.edu.au/resources/college-publications/australasian-anaesthesia-(the-blue-book)/blue-book-2017-(1)
The 2025 ILP student will present an abstract accepted for the 3CTS November2025 cardiac meeting ICC Sydney , and this will be an ongoing project for 2026 ILP.
3. 2015 - ROTEM Machine funding acquired
Role and Budget: I personally acquired $42,500 benevolent funding for the purchase of two ROTEM machines. The funds were deposited in the SCH Foundation and used for the purchase of these machines which continue to be used in cardiac theatre and cardiac ICU POW/SCH today.
Impact: Commencement of Goal directed bleeding management on Randwick campus as above.
4. 2013 - ECMO Machine funding acquired
Role and Budget: I personally acquired $60,000 benevolent funding for the purchase of one ECMO machine. The funds were deposited to the SCH Foundation, and the machine is kept in the Cardiac Perfusion department of POW/SCH. ECMO machines are used for respiratory failure and cardiac arrest patients where there is a reversible component to their condition, and heart/lung support may be continued for several days with this device then being weaned.
Impact: This device has been used to save many lives, and research has been local audit only.
DECIDE TRIAL -Principal Investigator POW Hospital -highest recruiting centre 37 patients as at September 2025
1. Ongoing since 2024 - DECIDE TRIAL (n-1100) -Four-year multi-Centre triple blind, placebo controlled, randomized trial evaluating whether dexmedetomidine improves days alive and free of delirium after cardiac surgery ETH 2023/PID02119
Funding Agency: NHMRC
Title: Dexmedetomidine in Cardiac surgical Intraoperative Drug Evaluation
Investigators: Profs Rob Sanders and Yahya Shehabi, Catherine Downs, Stefan Dielman (Westmead) Sharon McGregor (JHH) Nathalie Smith (St George) many Assoc Investigators listed on Regis at each site
My Role: Principal Investigator POW Hospital
Budget: $4,057,466
ClinicalTrials.ANZCTR Identifier: ACTRN 12623001171606
2. Ongoing since 2019 - UTERINE TRANSPLANT
Funding Agency: Royal Hospital for Women Foundation
Title: Uterus Transplantation as a treatment option for women with absolute uterine factor infertility 2019/ETH13038
Investigators: Prof Jason Abbott, Rebecca Deans, Jana Pitman (I am not a named investigator as it’s a surgical trial)
My Role: Anaesthesia advisor, I was present during surgery for the first transplant on 10th January2023 overseeing the anaesthesia protocols (accepted peer reviewed last author on publication 2025 in press in the International Journal Obstetric Anaesthesia-see publications)
Budget: $ undisclosed
ClinicalTrials. ANZCTR Identifier: ACTRN 12622000917730
3 . 2023 ongoing -TRICS IV-Multi-Centre open-label randomised controlled trial (RCT) of a restrictive versus liberal transfusion strategy in higher risk patients ≤65 years of age having cardiac surgery on cardiopulmonary bypass, using a superiority trial design. https://www.anzca.edu.au/profiles/ctn-trials/underway/trics-iv-trial
Funding Agency: NHMRC
Title: Multicentre TRICS IV: Liberal versus restrictive Transfusion Strategy in Cardiac Surgery. Investigators: Aine Duggan PI, Catherine Downs, Alyssa Scurrah, Mark Hertzberg (haematology) Ass Prof Peter Grant and Ass Prof Rob Turner
My Role: Associate Investigator
Budget: $869,565
ClinicalTrials.gov Identifier: NCT04754022
2021-2024 ITACS - Multi-Centre -2021/PID01408 (Regis) This randomised double-blind, controlled phase 4 trial will compare the efficacy, safety and cost-effectiveness of preoperative IV iron with placebo in patients with anaemia before elective cardiac surgery.
https://www.anzca.edu.au/profiles/ctn-trials/underway/itacs-trial Funding Agency: NHMRC
Complete
4. Title : Multicentre- IV Iron for treatment of Anaemia before Cardiac Surgery (ITACS) Trial.
Investigators: Alyssa Scurrah PI, Catherine Downs, Aine Duggan, Prof Michael Bennett, Ass Prof Peter Grant and Ass Prof Rob Turner
My Role: Associate Investigator
Budget: $2,285,290
ClinicalTrials.gov Identifier: NCT02632760
https://www.anzca.edu.au/profiles/ctn-trials/underway/itacs-trial
5. 2020 COVID-Multi-Centre May -August/PID01529 (Regis)
Funding Agency: Commonwealth Health Department
Title: Prevalence of Asymptomatic SARS-Cov-2 Infection in Elective Surgical Patients in Australia
Investigators: Catherine Downs (POW P), Matthew Doane (RNSH), Stefan Dieleman (Westmead) and Jenny Kok (NSW Health Pathology) National surveillance study. (3 centres in each state and territory)
My Role: SESLHD Principal Investigator SESLHD: At the peak of the early COVID pandemic three NSW hospitals were chosen by NSW Health
For SESLHD, I led the recruitment of 496 patients in June 2020. I arranged ethics approval and oversaw the theatre teams collecting nasal swabs and serology from most elective surgery patients at POW Private Hospital to determine the background prevalence of COVID at a time when Australia had shut its borders.
Budget: $340,419
Impact: Australian Government able to confirm a low background prevalence of COVID in Australia in June 2020, in fact SESLHD had the highest national prevalence of 5/496 with positive serology. No positive swabs.
Group authorship: I was-not named in publication, only as a SARS-CoV-2 Testing in Elective Surgery Collaborator, see publications
6. 2000 - 2002.- B AWARE study Multicentre.
Funding Agency: The B-Aware trial was funded by project grants from the Australian and New Zealand College of Anaesthetists, the Alfred Hospital Research Trust, Royal Hobart Hospital Research Foundation (S Swallow), and the Centre for Encouragement of Philanthropy in Australia. Title: Bispectral index monitoring to prevent awareness during anaesthesia: the B-aware randomised controlled trial
Investigators: Prof Paul Myles, Kate Leslie, Michael Beaudoin, Stephen Gatt (I am not a named investigator my department heads signed it off ) This really got me interested in trials.
My Role: I was not named as a site investigator, as a junior consultant I did not realise the importance of asking to be a named investigator. It was my idea and I coordinated ETHICS for POW cardiac unit and RHW to be included in this Multicentre trial. I was involved in recruiting high risk patients from Randwick campus and collecting and communicating their data.
Budget: $undisclosed
Impact: This led to widespread use of this monitoring technology GLOBALLY in patients undergoing high risk surgery.
Group authorship: I was not named in publication: Myles, P. S., Leslie, K., McNeil, J., Forbes, A., & Chan, M. T. (2004). Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet, 363(9423), 1757-1763. and two other publications from the lead team following up the patients who were aware under anaesthesia over time.
2025- REVIEWED GRANT PROPOSAL: ‘Peripartum Fibrinogen levels and the risk of postpartum haemorrhage-a pilot study’ for ANZCA Foundation-July 2025
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