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Trial registered on ANZCTR


Registration number
ACTRN12622000995774p
Ethics application status
Submitted, not yet approved
Date submitted
5/07/2022
Date registered
15/07/2022
Date last updated
15/07/2022
Date data sharing statement initially provided
15/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Tranexamic Acid and Cancer Recurrence after Gastrointestinal Cancer Surgery; A nested substudy of the Tranexamic Acid to Reduce Infection After Gastrointestinal Cancer Surgery (TRIGS) trial
Scientific title
Tranexamic Acid and Cancer Recurrence after Gastrointestinal cancer Surgery
Secondary ID [1] 307497 0
NIL
Universal Trial Number (UTN)
U1111-1280-0254
Trial acronym
TRIGS Cancer recurrence
Linked study record
This is a nested substudy of the Tranexamic Acid to Reduce Infection After Gastrointestinal Cancer Surgery (TRIGS) trial NCT04192435'

Health condition
Health condition(s) or problem(s) studied:
Cancer recurrence 326907 0
Gastric cancer 326908 0
Oesophageal cancer 326971 0
Hepatobiliary cancer 326972 0
Pancreatic cancer 326973 0
Colorectal cancer 326974 0
Condition category
Condition code
Cancer 324107 324107 0 0
Biliary tree (gall bladder and bile duct)
Cancer 324155 324155 0 0
Bowel - Anal
Cancer 324156 324156 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 324157 324157 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 324158 324158 0 0
Liver
Cancer 324159 324159 0 0
Oesophageal (gullet)
Cancer 324161 324161 0 0
Pancreatic
Cancer 324162 324162 0 0
Stomach

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
This substudy nested within the multicentre, pragmatic, double-blind, randomised TRIGS trial NCT04192435. Assessment will be completed once at 5 years post operatively via cancer registry and the National Death Index (NDI will compare cancer-free survival in patients receiving tranexamic acid, or matched p)lacebo, for gastrointestinal cancer surgery. All adult patients scheduled for elective or semi-elective open or lap-assisted gastrointestinal cancer surgery (oesophageal, gastric, hepatobiliary, pancreatic, colorectal) with one or more risk factors for complications, will be included.
Intervention code [1] 323955 0
Diagnosis / Prognosis
Comparator / control treatment
Patient recruited to the Trigs trial (NCT04192435) undergoing cancer surgery matched placebo) - A bolus of study drug, 0.15 ml/kg of placebo)) undergoing cancer surgery before surgical incision, and then infusion at 0.05 ml/kg/h until the end of surgery
Control group
Placebo

Outcomes
Primary outcome [1] 331911 0
Cancer-free survival form state cancer registries
Timepoint [1] 331911 0
5 years from Gastrointestinal surgery
Secondary outcome [1] 411583 0
All-cause 5-year mortality
Timepoint [1] 411583 0
5 years from Gastrointestinal surgery, will be collected from the National death Index (NDI)

Eligibility
Key inclusion criteria
Patients undergoing cancer surgery (oesophageal, gastric, hepatobiliary, pancreatic, colorectal) and enrolled in the TRIGS Trial (NCT04192435.)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
NONE

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Analyses will be modified intention-to-treat, whereby all patients randomly assigned to treatment group and undergo a surgical incision will be analysed according to the group to which they were assigned. Survival outcomes will be analysed using Cox proportional hazards model, adjusting for the stratifying variable of diabetes status, and adjusting for cancer staging at the time of surgery (spread yes/no), with results expressed as hazard ratios and 95% CI. Baseline characteristics of the two randomised groups will be tabulated and compared using appropriate summary statistics. Time to recurrence and, separately, time to death from any cause will be compared graphically between groups by Kaplan-Meier survival curves, summarized by median times to event with interquartile ranges, and assessed using the Cox proportional hazards model, adjusting for the stratifying variable of diabetes status. Cox proportional hazards model will be used to adjust for imbalances of potentially important covariates, with assessment of the requisite proportionality assumptions.
The effect of treatment on primary and secondary outcomes in pre-specified subgroups based on patient sex, age, diabetes, ASA physical status, surgery type, and cancer staging at the time of surgery (spread yes/no), will be assessed through the inclusion of treatment-by-subgroup interaction terms in regression models. All reported P values will be 2-sided and not adjusted for multiple comparisons. Multiple imputation will be applied to assess the sensitivity of results to missing outcome data if the proportion of missingness is >5%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
1400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 22714 0
The Alfred - Melbourne
Recruitment hospital [2] 22715 0
Frankston Hospital - Frankston
Recruitment hospital [3] 22716 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 22717 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [5] 22718 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [6] 22719 0
Epworth Richmond - Richmond
Recruitment hospital [7] 22720 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [8] 22721 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [9] 22722 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [10] 22723 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [11] 22724 0
Footscray Hospital - Footscray
Recruitment hospital [12] 22725 0
The Avenue Private Hospital - Windsor
Recruitment hospital [13] 22727 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [14] 22728 0
Werribee Mercy Hospital - Werribee
Recruitment hospital [15] 22729 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [16] 22730 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment hospital [17] 22731 0
La Trobe Private Hospital - Bundoora
Recruitment hospital [18] 22732 0
Northeast Health Wangaratta - Wangaratta
Recruitment hospital [19] 22733 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [20] 22734 0
Gosford Hospital - Gosford
Recruitment hospital [21] 22735 0
Westmead Hospital - Westmead
Recruitment hospital [22] 22736 0
John Hunter Hospital - New Lambton
Recruitment hospital [23] 22737 0
Blacktown Hospital - Blacktown
Recruitment hospital [24] 22738 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [25] 22739 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [26] 22740 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [27] 22741 0
Wollongong Hospital - Wollongong
Recruitment hospital [28] 22742 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [29] 22743 0
Royal Hobart Hospital - Hobart
Recruitment hospital [30] 22744 0
Gold Coast Hospital - Southport
Recruitment hospital [31] 22745 0
The Prince Charles Hospital - Chermside
Recruitment hospital [32] 22746 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [33] 22747 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [34] 22748 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [35] 22749 0
Caboolture Hospital - Caboolture
Recruitment hospital [36] 22750 0
Mackay Base Hospital - Mackay
Recruitment hospital [37] 22751 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [38] 22752 0
Logan Hospital - Meadowbrook
Recruitment hospital [39] 22753 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [40] 22754 0
Royal Perth Hospital - Perth
Recruitment hospital [41] 22755 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 38017 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 38011 0
2031 - Randwick
Recruitment postcode(s) [3] 38018 0
2050 - Camperdown
Recruitment postcode(s) [4] 38013 0
2145 - Westmead
Recruitment postcode(s) [5] 38015 0
2148 - Blacktown
Recruitment postcode(s) [6] 38012 0
2250 - Gosford
Recruitment postcode(s) [7] 38014 0
2305 - New Lambton
Recruitment postcode(s) [8] 38016 0
2485 - Tweed Heads
Recruitment postcode(s) [9] 38019 0
2500 - Wollongong
Recruitment postcode(s) [10] 37993 0
3004 - Melbourne
Recruitment postcode(s) [11] 38003 0
3011 - Footscray
Recruitment postcode(s) [12] 38007 0
3030 - Werribee
Recruitment postcode(s) [13] 38001 0
3050 - Parkville
Recruitment postcode(s) [14] 38002 0
3065 - Fitzroy
Recruitment postcode(s) [15] 38009 0
3083 - Bundoora
Recruitment postcode(s) [16] 37995 0
3084 - Heidelberg
Recruitment postcode(s) [17] 37998 0
3121 - Richmond
Recruitment postcode(s) [18] 37997 0
3128 - Box Hill
Recruitment postcode(s) [19] 38006 0
3144 - Malvern
Recruitment postcode(s) [20] 38000 0
3168 - Clayton
Recruitment postcode(s) [21] 38004 0
3181 - Windsor
Recruitment postcode(s) [22] 37994 0
3199 - Frankston
Recruitment postcode(s) [23] 37999 0
3220 - Geelong
Recruitment postcode(s) [24] 37996 0
3350 - Ballarat Central
Recruitment postcode(s) [25] 38008 0
3630 - Shepparton
Recruitment postcode(s) [26] 38010 0
3677 - Wangaratta
Recruitment postcode(s) [27] 38026 0
4020 - Redcliffe
Recruitment postcode(s) [28] 38025 0
4029 - Herston
Recruitment postcode(s) [29] 38023 0
4032 - Chermside
Recruitment postcode(s) [30] 38024 0
4102 - Woolloongabba
Recruitment postcode(s) [31] 38029 0
4108 - Coopers Plains
Recruitment postcode(s) [32] 38030 0
4131 - Meadowbrook
Recruitment postcode(s) [33] 38022 0
4215 - Southport
Recruitment postcode(s) [34] 38027 0
4510 - Caboolture
Recruitment postcode(s) [35] 38028 0
4740 - Mackay
Recruitment postcode(s) [36] 38020 0
5000 - Adelaide
Recruitment postcode(s) [37] 38032 0
6000 - Perth
Recruitment postcode(s) [38] 38031 0
6008 - Subiaco
Recruitment postcode(s) [39] 38033 0
6009 - Nedlands
Recruitment postcode(s) [40] 38021 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 311812 0
Self funded/Unfunded
Name [1] 311812 0
Country [1] 311812 0
Primary sponsor type
University
Name
Monash University
Address
Monash University
of Wellington Road, Clayton, Victoria Australia 3800
Country
Australia
Secondary sponsor category [1] 313246 0
None
Name [1] 313246 0
Address [1] 313246 0
Country [1] 313246 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311217 0
Alfred Hospital research and Ethics committee
Ethics committee address [1] 311217 0
Alfred Health
55 commercial road
Melbourne 3004
Vic
Ethics committee country [1] 311217 0
Australia
Date submitted for ethics approval [1] 311217 0
06/07/2022
Approval date [1] 311217 0
Ethics approval number [1] 311217 0

Summary
Brief summary
Tranexamic acid is an antifibrinolytic drug routinely used to reduce bleeding in cardiac and some orthopaedic surgery, which has also been shown to affect immune function and inflammation. There is a strong biological rationale suggesting that tranexamic acid may reduce micrometastases at the time of surgery and so reduce the risk of longer term cancer-recurrence. Therefore, the aim of this nested study is to assess the cancer-free survival of a subpopulation of participants involved in the TRIGS trial (NCT04192435) undergoing surgery for gastrointestinal cancer, who are planned to receive either tranexamic acid or placebo.

Who is it for?
You may be eligible for this study if you are aged 18 years or over, are enrolled in the TRIGS trial, and are scheduled for elective or semi-elective (inpatient) open or laparoscopic-assisted (i.e. keyhole) gastrointestinal cancer surgery (oesophageal, gastric, hepatobiliary, pancreatic, colorectal).

Study details
All participants will be assessed for cancer-free survival at 5 years after gastrointestinal surgery using state cancer registries to determine the incidence of all-cause mortality and overall survival at 5 years post-surgery.

It is hoped that this study may show tranexamic acid improves cancer-free survival, improves overall survival, and reduces all-cause mortality when administered at the time of gastrointestinal cancer surgery, which may help to guide the treatment of gastrointestinal cancer patients in future.
Trial website
www.trigs.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120366 0
Prof Paul Myles
Address 120366 0
Department of Anaesthesiology and Perioperative Medicine
55 Commercial Road
Melbourne VIC 3004
Country 120366 0
Australia
Phone 120366 0
+613 90762651
Fax 120366 0
+613390768076
Email 120366 0
p.myles@alfred.org.au
Contact person for public queries
Name 120367 0
Miss Sophie Wallace
Address 120367 0
Department of Anaesthesiology and Perioperative Medicine
55 Commercial Road
Melbourne VIC 3004
Country 120367 0
Australia
Phone 120367 0
+61 390762651
Fax 120367 0
+613390768076
Email 120367 0
s.wallace@alfred.org.au
Contact person for scientific queries
Name 120368 0
Prof Paul Myles
Address 120368 0
Department of Anaesthesiology and Perioperative Medicine
55 Commercial Road
Melbourne VIC 3004
Country 120368 0
Australia
Phone 120368 0
+613 90763176
Fax 120368 0
+613390768076
Email 120368 0
p.myles@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Initial approval from AIHW will be required prior to IPD sharing to be ticked


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.