The TRIGS Trial: Tranexamic acid to Reduce Infection after Gastrointestinal Surgery is headed by Professor Paul Myles at Monash University and Alfred Health.
The TRIGS trial is a multicentre, pragmatic, double-blind, randomised clinical trial will compare the incidence of surgical site infection and red cell transfusion requirements after IV tranexamic acid and placebo in patients undergoing gastrointestinal surgery. The trial has now received the drug in Australia and shipments to sites will commence in the coming days. Recruitment commenced on 16 November 2020. Per patient payment: $A1000
Per patient payment: $A1000
The HAMSTER trial: High-flow for Children’s Airway Surgery; a randomised Controlled Trial.
The HAMSTER trial is a multi-centre project investigating the role of high-flow during paediatric upper airway surgery and is now recruiting at five sites including Queensland Children’s Hospital, Perth Children’s Hospital, Women and Children’s Hospital, Adelaide, Royal Children’s Hospital, Melbourne and The Children’s at Hospital, Westmead. All regulatory requirements and approvals have been achieved and site visits for study set up and education performed early in 2019.
This trial is led by Dr Susan Humphreys at Queensland Children’s Hospital and has received a total of $A583,000 from SPANZA, ANZCA and Thrasher Research Foundation. The primary outcome for the study is the incidence of rescue oxygenation attempts for hypoxaemic events during tubeless airway surgery comparing high flow nasal oxygen to low flow oxygen.
Recruitment commenced in September 2018 and is expected to be completed mid 2021. Total patient recruitment target is 530 with 470 currently recruited. After a three month halt in the trial due to COVID, recruitment has commenced again and is expected to be completed mid 2021.
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The MASTERSTROKE study: Management of Systolic blood pressure during Thrombectomy by Endovascular Route for acute ischaemic STROKE
MASTERSTROKE is a pragmatic, prospective, double blind, randomized, multicentre clinical trial. The aim is to assess the influence of induced hypertension (IH) during general anaesthesia for thrombectomy involving stroke patients. The primary outcome is functional recovery at 90 days as measured by the modified Rankin Scale. Anaesthetists will be asked to target a systolic blood pressure target of 140 mm Hg or 170 mm Hg from case start until the target vessel is recanalised or case completion if recanalisation is not achieved. The trial has received a total of $NZ490,000 from the Auckland District Health Board Research Trust, The Auckland Medical Research Foundation and the Neurological Foundation of New Zealand in order to fund the project office, database and New Zealand recruitment. Dr Doug Campbell is supported by a two year Senior Clinical Research Fellowship from the Neurological Foundation of New Zealand to help administer the trial.
Recruitment has started at Auckland City Hospital despite the COVID-19 pandemic. We have recruited 90 patients to date. Christchurch Hospital has their regulatory approvals in place and is about to start recruiting. University Medical Centre, Groningen, Netherlands have been delayed by the international shutdown but have secured local funding and are proceeding with ethics application. The Australian ethics application is being initiated by Allison Kearney and David Highton at Princess Alexandra Hospital in Brisbane. Australian sites wanting more information or wishing to register interest.
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The NATO study: The Non-Anaemic iron deficiency and Treatment Outcomes after colorectal cancer surgery study is led by Dr Lachlan Miles from the University of Melbourne and Austin Health. The study manager is Ms Anna Parker.
The NATO study is a prospective observational study performed in patients undergoing surgery for colorectal cancer, comparing non-anaemic patients with iron deficient to those who are iron replete. The primary outcome is days alive and out of hospital at postoperative day 90, with important secondary outcomes examining incidence of postoperative complications, readmission and quality of life. The study has received $A200,000 from a variety of government, public, private and industry funders. The study commenced recruitment on 7 May 2019, and is presently enrolling participants at 14 sites across Australia, with a recruitment of the planned cohort of 422 patients now at 25 per cent after a delay due to COVID-19 restrictions. Per patient payment is $A400 from enrolment to the completion of 90-day follow-up.
The IV iron for Treatment of Anaemia before Cardiac Surgery study is a randomised double-blind, controlled phase IV trial that will compare the efficacy, safety and cost-effectiveness of preoperative IV iron with placebo in patients with anaemia before elective cardiac surgery.
The trial is now recruiting at 20 centres in New Zealand, Australia, South Africa, Singapore, Hong Kong, Malaysia, Abu Dhabi, Canada and the United Kingdom. As a result of the worldwide COVID pandemic recruitment to the ITACS trial has dramatically reduced but many countries are now in the process of commencing recruitment. The trial has recruited 566 patients worldwide.
Per patient payment: $A1100 per patient.
The T-REX trial aims to determine if low-dose sevoflurane/dexmedetomidine/remifentanil anaesthesia is associated with superior neurodevelopmental outcome, compared to standard-dose sevoflurane anaesthesia, in children less than two years of age, having anaesthesia expected to last two hours or longer. The trial is led by Professor Andrew Davidson at the Murdoch Children's Research Institute (MCRI). The trial has enrolled 162 patients at sites in Australia, the US and Italy. The T-REX trial team is pleased to report the following:
- There are currently seven actively recruiting sites in Australia: Royal Children’s Hospital Melbourne; Queensland Children’s Hospital; Sydney Children’s Hospital; Perth Children’s Hospital and The Children’s Hospital at Westmead, Flinders Medical Centre and the Women’s and Children’s Hospital in Adelaide. The trial received a big boost in October when Gaslini Children’s Hospital in Genoa Italy recruited their first participant. Further Italian sites are expected to join shortly.
- Follow up assessments have commenced in Melbourne, Sydney, Brisbane and Dallas.
Contact the MCRI
The Reduction Of Chronic Post-surgical Pain with Ketamine (ROCKet) trial is a five-year, 4884-patient, multicentre, double-blind, placebo controlled, phase 3/4 randomised controlled trial of the effect of up to 72 hours of perioperative ketamine on the risk of development of chronic post-surgical pain. The trial is led by Professor Philip Peyton at the Univeristy of Melbourne and Austin Hospital.
The trial has randomised 1767 participants at 30 sites in Australia and Hong Kong. Recruitment has improved over the past couple of months, following the easing of COVID restrictions and increase in elective surgery.
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Preclinical and retrospective clinical research suggests that propofol-TIVA may associate with improved disease-free survival and overall survival when compared with inhalational anaesthesia for cancer surgery. VAPOR-C will explore the impact of anaesthetic technique on disease-free survival after cancer surgery. The target recruitment is 5736 participants with stage 1-3 (curative intent) colorectal cancer or non-small-cell lung cancer scheduled for surgical resection.
The VAPOR-C project is now active and recruiting patients. We have 7 active sites, and the governance review process is underway at a further 15 Australian sites. The project is also in the start-up phase in NZ, the US and Canada. Thank you everyone for your ongoing support.
The per patient payment is $A675 and a site start up payment of $A750.
The Chewy Trial is a multicentre, randomised, controlled trial of chewing gum vs. ondansetron for post-operative nausea and vomiting in women and girls having laparoscopic or breast surgery. We thank all our sites and collaborators for their hard work during 2020 in continuing trial recruitment, we are now back up and running at full steam! Chewy is over one-third of the way to completion, with 409 patients recruited and 111 randomised across 16 active sites in Australia and New Zealand (target: 272 randomised patients). We welcome more sites interested in joining the Chewy team.
The primary hypothesis for the study is that chewing gum (one stick of Wrigley's peppermint-flavoured gum, chewed for 15 minutes) is non inferior to 4mg IV ondansetron in achieving complete cessation of nausea, retching and vomiting postoperatively, within two hours of administration, with no recurrence of nausea and no need for rescue medication. This has the potential to dramatically change the management of one of the most common complications of anaesthesia worldwide.
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The Perioperative Ischemic Evaluation-3 (POISE-3) trial will examine the safety and efficacy of tranexamic acid and the effect of a hypotension-avoidance strategy on ischaemic and bleeding endpoints in major noncardiac surgery in 10,000 participants.
We have reached more than 75 per cent of our target recruitment with more than 7650 participants recruited globally from 103 sites. In Australia and New Zealand, 557 participants have been recruited from our 20 activated sites. If you are interested in post-op delirium and cognition then the CogPOISE-3 substudy may interest you. More than 1550 patients have been recruited to CogPOISE-3 and there is still plenty of time for sites to part.
Freezing platelets using DMSO as a cryoprotectant extends shelf-life from five days to two years.
Following a successful pilot study in four hospitals (Transfusion, 2019), the CLIP investigators (a collaboration of the ANZCA CTN, ANZICS CTG, Australian Defence Force, Australian Red Cross Blood Service and Australian civilian hospitals) designed a definitive trial that will recruit 808 high-risk cardiac surgery patients, to achieve 202 patients actually transfused platelets. A platelet risk prediction tool, the Australian Cardiac Surgery Platelet Transfusion (ACSePT) score, incorporating relevant variables, has been developed using local data.
The protocol has ethics approval, and all study procedures are in place. Sufficient platelets will have been manufactured for the first patients to be enrolled in early 2021. Engagement with twelve selected study sites has progress through 2020. In New Zealand, an investigative team led by Dr Shay Mc Guinness and Associate Professor Rachael Parke, has received funding from the NZ Health Research Council (HRC) to run a parallel protocol using cryopreserved platelets manufactured by a slightly different technique.
For more information on the CLIP-II study, please refer to the ANZIC-RC webpage or clinicaltrials.gov registration NCT03991481
The DECS-II trial is a multicentre, pragmatic, assessor-blinded, randomised trial of dexamethasone (1mg/kg, single dose) versus placebo, in patients undergoing cardiac surgery, employing a novel, highly efficient trial design. The trial is led in Australia by Professor Paul Myles, with Dr Stefan Dieleman and Dr Lieke Verheijen in Utrecht, Netherlands. Total sample size is 1400 patients from each county. Australia has recruited 860 patients from The Alfred hospital, Monash Medical Centre, Geelong Hospital, Royal Adelaide and Westmead Hospital. The Netherlands is recruiting at one centre with three further sites in ethics.
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The Long-term Outcomes of Lidocaine Infusions for persistent PostOperative Pain in patients undergoing breast cancer surgery (LOLIPOP) trial
In a landmark achievement, a team led by Deputy Chair of the ANZCA Clinical Trials Network, Professor Tomás Corcoran, secured a $A4.3 million grant from the Medical Research Future Fund to perform the LOLIPOP trial. The five year LOLIPOP trial is a large (n=4400) pragmatic, multicentre, randomised, stratified, controlled, superiority trial evaluating the effect of lidocaine infusions in the intra- and postoperative periods on the incidence of moderate or severe chronic post-surgical pain (CPSP) at one year in patients undergoing elective breast cancer surgery. Secondary outcomes will include analgesic efficacy (pain scores), psychological and quality of life outcomes, the influence of pharmacogenomic profile on efficacy, and cost-effectiveness.
Study hypothesis: The administration of a lidocaine infusion intraoperatively and up to 24 hours postoperatively reduces the incidence of moderate or severe CPSP following breast cancer surgery compared with placebo.
Please email Professor Tomas Corcoran if you are at all interested in being involved, with your contact details and any questions.
Transfusion Requirements in Cardiac Surgery (TRICS IV) trial
The TRICS IV study is designed to determine whether a liberal transfusion strategy is superior to a restrictive strategy in cardiac patients < 65 years. TRICS IV will incorporate an innovative pragmatic Bayesian design to include patients recruited to TRICS III in its sample size estimation and analysis. It will also include the option of physiologic triggers for transfusion, in addition to the above Hb based thresholds. As for TRICS III, this study is being led by Professor David Mazer’s group from Canada with Canadian Institutes of Health Research (CIHR) funding and will involve an international collaboration. We have secured National Health and Medical Research Council MRFF International Collaborative Trials funding of $A870k for the Australian arm of this study, which will include a local iron availability sub-study. We plan to recruit 500 adult cardiac surgical patients (Euroscore ≥ 6) through multiple Australian sites over three years. Those involved with TRICS III will find the trial conduct and management very familiar.
Please email Professor David Scott if you are interested in being involved, with your contact details and any questions.
We would to take this opportunity to thank all the hard-working people, nationally and internationally, who contribute to the success of our multicentre research.