The TRIGS trial
The TRIGS Trial: Tranexamic acid to Reduce Infection after Gastrointestinal Surgery is headed by Professor Paul Myles at Monash University and Alfred Health.
The ITACS trial will compare efficacy, safety and cost-effectiveness of preoperative IV iron with placebo in patients with anaemia before elective cardiac surgery. ITACS has enrolled 505 patients of the 1000 patients required. 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.
Per patient payment: $A1000
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 had started at Auckland City Hospital prior to the COVID-19 pandemic. All trial recruitment and preparations to start recruitment at Christchurch Hospital and University Medical Centre, Groningen, Netherlands have been delayed by the international shutdown. We will try to initiate Australian recruitment once the clinical situation with COVID-19 is clearer. Australian sites wanting more information or wishing to register interest.
Contact the ADHB
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.
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 142 patients at sites in Australia and the US. 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.
- Follow up assessments have commenced in Melbourne, Sydney, Brisbane and Dallas.
- Italy is expected to start recruitment in shortly.
Contact the MCRI
The Reduction Of Chronic Post-surgical Pain with Ketamine (ROCKet) study 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 is progressing well with 1492 patients in Australia and Hong Kong, from 32 activated sites. New Zealand sites are preparing to commence shortly.
Find out more
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 has ethics approval, and recently underwent a small amendment which is also now approved. The governance review process is taking place at 15 Australian sites. Due to COVID-19, VAPOR-C was placed in hold for three months, however we have now begun site initiations in Australia, and pleased to report the first patient was randomised by Princess Alexandra Hospital on August 28, 2020.
The per patient payment is $A675.
The Chewy trial
The Chewy Trial is a multicentre, randomised, controlled trial of chewing gum vs. ondansetron for post-operative nausea and vomiting in women having laparoscopic or breast surgery. We thank all our sites and collaborators for their incredible hard work through the COVID-19 pandemic in continuing trial recruitment. Despite these challenges, Chewy is now more than one-third of the way to completion, with 380 patients recruited and 100 randomised across 14 active sites in Australia and New Zealand (target: 272 randomised patients). We look forward to a further three sites joining us in the coming weeks.
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 PONV worldwide.
Follow us on Twitter
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.
To date, more than 7017 participants have been recruited globally from 99 sites. In Australia and New Zealand, 482 participants have been recruited from our 19 activated sites. We also have further sites who are preparing to be activated. If you are interested in post-op delirium and cognition then the CogPOISE-3 substudy may interest you. To date, more than 1000 patients have been recruited to CogPOISE-3 and plenty of time for sites to still take 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 mid to late-2020. Engagement with twelve selected study sites will progress through 2020. Subject to funding, a parallel protocol is hoped to run in New Zealand, led by Dr Shay Mc Guinness and Associate Professor Rachael Parke, 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
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 740 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.
Contact the trial
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.