None listed
Conditions
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, hepatobiliary, pancreatic, colorectal) with one or more risk factors for complications, will be included.
Sponsors
Eligibility
Inclusion criteria
Patients undergoing cancer surgery (oesophageal, gastric, hepatobiliary, pancreatic, colorectal) and enrolled in the TRIGS Trial (NCT04192435.)
Exclusion criteria
NONE