Skip to content

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

Tranexamic Acid and Cancer Recurrence after Gastrointestinal cancer Surgery

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622000995774
Acronym
TRIGS Cancer recurrence
Enrollment
1400
Registered
2022-07-15
Start date
2022-08-01
Completion date
2025-12-31
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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, hepatobili

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.

Sponsors

Monash University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients undergoing cancer surgery (oesophageal, gastric, hepatobiliary, pancreatic, colorectal) and enrolled in the TRIGS Trial (NCT04192435.)

Exclusion criteria

NONE

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026