I hold a current NIDA Clinical Trials Network Good Clinical Practice Certificate
ORCID ID: orcid.org/0009-0005-5048-8221
ITACS:- 2021/PID01408 (Regis)
Title : IV Iron for treatment of Anaemia before Cardiac Surgery (ITACS) Trial.
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.
In 2020 I coordinated an audit of preoperative anaemia in cardiac surgery patients on Randwick Campus and confirmed that we could have one patient per month to potentially enrol in the multicentre ITACS study. This is run via the ANZCA Clinical Trials Network and the coordinating principal Investigator is located at Monash in Melbourne. https://www.anzca.edu.au/profiles/ctn-trials/underway/itacs-trial/
Funding Agency: NHMRC
Budget: $2,285,290
Role: Associate Investigator. Recruiting for this project requires the coordination of the surgical registrars, anaesthetists and nurses. We have recruited 11 patients, randomised to placebo or IV Iron more than one week before cardiac surgery, followed by series of data and questionnaires that are completed over a 6-month period.
Impact: The optimization of patient’s blood prior to surgery is the first pillar of patient blood management. Recruitment will be completed at the end of 2023 and the outcome of this will shape clinical practice in future.
TRICS IV:- 2023/PENDING (Regis)
Budget: $869,565
Title : Liberal versus restrictive transfusion strategy for cardiac surgery. This international multicentre, open-label, randomised control trial from Canada is recruiting Australian hospitals through the ANZCA trials network. We recently completed Ethics application 2024 with a view to recruiting one patient per month (we don’t do many high-risk younger patients). This is a superiority trial aiming to recruit 1,440 patients internationally.
https://www.anzca.edu.au/profiles/ctn-trials/underway/trics-iv-trial/
Funding Agency: POW Foundation 2023
Title : A prospective audit: monitoring the use of ROTEM for transfusion in critically bleeding patients on Randwick Campus.
Role: Co-ordinating Principal Investigator
Budget: $600 for advertising of the 2023 audit QR code and creation of an advanced educational Video.
Impact: This project resulted in many presentations and publications, including 12 Randwick Campus presentations to the POW/SCH/POWPH/RHW anaesthetic departments, and I’ve presented twice at ICU grand rounds. The data was published in a book chapter in Australasian Anaesthesia 2017 “Introducing Viscoelastic haemostatic assay guided blood product transfusion into your hospital “page 77-94.
https://www.anzca.edu.au/resources/college-publications/australasian-anaesthesia-(the-blue-book)/blue-book-2017-(1)
This project was also presented at an international Haematology meeting by Dr Susan Macallum (Chair transfusion committee and haematologist), and I also presented orally as an invited speaker at an international conference in Antarctica and the National ANZCA anaesthesia meeting in Darling Harbour, and in 2021 on a webinar panel for a national meeting with international speakers. In collaboration with a registrar, we presented a poster at the ANZCA national meeting titled “Use of ROTEM®: does surgical specialty influence transfusion practice?” at Leaps and Bounds National ANZCA meeting May 2021. I am the chair of the Rotem Working Party, responsible for the implementation, education and audit of ROTEM guided transfusion, this is a multidisciplinary task which has been the biggest change to transfusion management on campus since the introduction of transfusion packs. As a result of my profile with the book chapter, I have been an invited speaker, attending in person the Werfen Asia Pacific Blood Management meeting in Thailand in March 2023, and I was on Faculty presenting live online at the Certificate course in patient Blood Management , WERFEN India with over 1000 registrants worldwide.
In 2023 this audit was re-launched as a redcap project (previously a paper data collection form in 2019) and QR codes at point of care have been created and a new redcap data collection form created by me, is being rolled out. The QR video 2024 is on this website under educational resources.
In 2015 I personally acquired $42,500 privately for the purchase of two ROTEM machines on Randwick Campus. I have established the ROTEM working party as a subcommittee of the Transfusion committee for Randwick Campus and I have developed evidence based transfusion algorithms in collaboration with haematology. These have recently been updated for 2023 and I have also developed a decision support tool for cardiac bleeding that I have presented internationally. I contribute to, and have access to the ANZCTS cardiac surgical database and use it for research into local and comparative national cardiac surgical transfusion and outcome data.
I am the coordinating Principal Investigator for the ROTEM audit: 2019/PID12980 (Regis) , and also involved with the Multicentre TRICS IV and ITACS studies.
The big goal of this project, already being realised, is, optimising blood product transfusion practice across the hospitals on Randwick campus and beyond. I will continue to lead the Randwick Campus ROTEM working party and the NSW wide ROTEM group leading new sites as they implement this evolution in bleeding management .
I will create the educational resources and programme to ensure staff at every level are aware of the process and their role .
I will continue to lead the ROTEM audit which will bring data to analyse and assist as we evolve best practice, whilst educating all involved on better management of critical bleeding.
I will continue to engage with WERFEN and present if invited as a speaker at any meeting where it is possible for me to attend.
For the past 15 years I have been involved in research protocols with the Gynaecological Research and Clinical Evaluation group, UNSW (GRACE), advising on protocols in surgical trials with Prof Jason ABBOTT (chair UNSW, GRACE). This has included:
Title :Uterine Transplant Project – 2019/ETH13038
Role : I have assisted with protocols and was present during surgery for the first Australian Uterine transplant on 10th January 2023
Impact: There is little literature on the anaesthetic considerations for this surgery. In May 2023 we presented a poster “Anaesthesia for uterine transplant-the first Australian experience” at both the ANZCA national meeting and the obstetric SIG meeting in Sydney.
This operation also had significant media coverage including on 60 minutes on 26th February 2023 .
May 2020 -August 2020/PID01529 (Regis)
Funding Agency: Commonwealth Health Department Multicentre via ANZCA Trials Network
Budget: $340,419
Title : Prevalence of Asymptomatic SARS-Cov-2 Infection in Elective Surgical Patients in Australia
Role: Principal Investigator SESLHD
At the peak of the pandemic three NSW hospitals were chosen by NSW Health as part of a National surveillance study. For SESLHD, I led the recruitment of 496 patients in June 2020. We had the second highest recruitment in the country, behind a centre in WA that continued collection into July. I arranged ethics approval and oversaw the theatre teams collecting nasal swaps 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.
Impact: PUBLISHED: SESLHD had the highest rate of background prevalence of COVID in Australia with 5 of our 496 patients having positive serology, and no active positive cases.
Prevalence of asymptomatic SARS-COV-2 infection in elective surgical patients in Australia: a prospective surveillance study. - Coatsworth N, Myles PS, Mann GJ, Cockburn IA, Forbes AB, Gardiner EE, Lum G, Cheng AC, Gruen RL, and the SG,-CoV-2 Testing in Elective Surgery Collaborators. ANZ J Surg 2020. https://pubmed.ncbi.nlm.nih.gov/33421257/
2016 Peer Review Journal publication
A novel Technique of Intraoperative Lateral Pectoral Nerve Block during Subpectoral Breast Implant Placement. https://pubmed.ncbi.nlm.nih.gov/27257576/
2005 Book Chapter in Australasian Anaesthesia: Analgesia After Thoracotomy: The Role of the Extrapleural Paravertebral Catheter. Cook E, Downs C. Australasian Anaesthesia 2005, page 103- 117. https://airr.anzca.edu.au/anzcacrisjspui/bitstream/11055/951/1/Australasian%20Anaesthesia%202005.pdf
1997- Peer Review Journal publication
Continuous extrapleural intercostal nerve block for post thoracotomy analgesia in children. Downs CS, Cooper MG. Anaesth Intensive Care. 1997 Aug; 25(4):390-7.
https://pubmed.ncbi.nlm.nih.gov/9288383/
Title : Bispectral index monitoring to prevent awareness during anaesthesia: the B-aware randomised controlled trial 2000 - 2002.
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.
Role: As a junior consultant it was my idea and I coordinated 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.
PUBLISHED LANCET 2004 P S Myles: https://pubmed.ncbi.nlm.nih.gov/15172773/
Impact: This led to widespread use of depth of anaesthesia monitoring technology in patients undergoing high risk surgery, and today it is in mainstream use
Role and Budget: I personally acquired $60,000 privately for the purchase of one ECMO machine at a time when we were recovering from the swine flu epidemic (where many young people needed ECMO). 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 machine continues to be used to support patents in respiratory failure and with reversible causes of cardiac arrest.
Copyright © 2024 Dr Catherine Downs - All Rights Reserved.
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