The TRIGS trial
The TRIGS Trial: Tranexamic acid to Reduce Infection after Gastrointestinal Surgery is headed by Professor Paul Myles, FANZCA.
In 2019, the NHMRC awarded a $A5.2 million grant for the TRIGS Trial. This multicentre, pragmatic, double-blind, randomised clinical trial will compare the incidence of surgical site infection at 30 days and red cell transfusion requirements after IV tranexamic acid and placebo in 3300 patients undergoing gastrointestinal surgery. A bolus of study drug, 0.15 ml/kg (TxA) 15 mg/kg or matched placebo) before surgical incision, and then infusion at 0.05 ml/kg/h until the end of surgery. We hope to receive the first shipment of drug in August 2020.
Per patient payment: $A1000
Endovascular thrombectomy is an exciting new therapy, but little is known about how these patients should be managed physiologically during the management of these patients.
The Management of Systolic Blood Pressure During Thrombectomy by Endovascular Route for Acute Ischaemic Stroke (MASTERSTROKE) study, led by Dr Doug Campbell and endorsed by ANZCA CTN, is a 550-patient study of patients undergoing endovascular thrombectomy for acute anterior large vessel ischaemic stroke. It looks at the role of induced hypertension during the ischaemic phase on functional recovery at three months.
It has received $NZ490,000 of funding from the Auckland Medical Research Foundation, the Auckland Hospital Research Trust and the New Zealand Neurological Foundation. Recruitment has started in New Zealand and the trial will recruit at several centres in New Zealand, Australia and the Netherlands.
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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, Canada, Hong Kong and the United Kingdom. We have sites from Germany and Ireland navigating the ethics process.
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 133 patients at sites in Australia and the United States. 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. We were excited to recently have Flinders Medical Centre and the Women’s and Children’s Hospital join us and both sites have already recruited their first participant.
- Follow up assessments have commenced in Melbourne, Sydney, Brisbane and Dallas.
- Several new sites in Italy expected to start shortly.
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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. It has so far recruited 1200 patients from 30 activated sites.
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Pre-clinical 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.
The Volatile Anaesthesia and Perioperative Outcomes Related to Cancer (VAPOR-C) trial will explore the impact of anaesthesia technique on disease-free survival after cancer surgery. The target recruitment is 5736 participants 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 the governance review process is taking place at 15 Australian sites. We anticipate site initiations will occur in June 2020, with the first patient enrolled in July 2020.
The Chewy trial
The Chewy trial is a multicentre, randomised, controlled trial that will recruit women having laparoscopic or breast surgery, with the aim of randomising 272 women who experience nausea in the post anaesthesia care unit (PACU). It is estimated that 30 per cent of women recruited to the study will experience these symptoms.
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.
The trial is actively recruiting at 14 sites throughout Australia and New Zealand, with 296 patients enrolled and 80 patients randomised as of May, 2020. We anticipate a total of 20 sites will be recruiting patients by the end of the year. Thanks to all sites and collaborators for their hard work.
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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.
To date, more than 5600 participants have been recruited globally from more than 90 sites. In Australia and New Zealand, 320 participants have been recruited from our 17 activated sites. There are two new substudies, CogPOISE-3 investigating cognition and delirium in patients, and the NTproBNP substudy.
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 Cryopreserved Versus Liquid Platelets for Surgical Bleeding (CLIP-II) trial 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 5 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 2020. Engagement with twelve selected study sites will progress through mid 2020. Subject to funding, a parallel protocol is hoped to run in New Zealand, led by Shay Mc Guinness and 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 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 Karin Munting in Utrecht, Netherlands. Total Sample size is 1400 patients from each county. Australia has recruited 614 patients from Monash Medical Centre, Geelong Hospital, Royal Adelaide, and Westmead Hospital. now recruiting and three Australian centres in ethics. The Netherlands is recruiting at one centre with three further sites in ethics.
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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.