NCT05470816 · Phase 3 · ACTIVE NOT RECRUITING
Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial
This trial is testing whether tranexamic acid, a drug that reduces bleeding and inflammation, can lower the chances of delirium after major gastrointestinal surgery. Delirium is a sudden state of confusion common after surgery, especially in older adults, and it is linked to longer-term cognitive decline. This is a Phase 3 trial, meaning researchers are testing whether it actually works at scale — not just whether it is safe.
Eligibility criteria
Inclusion criteria * Adult patients scheduled for elective gastrointestinal (oesophageal, gastric, hepatobiliary, colorectal) surgery * with 2 or more risk factors for complications: * age ≥70 years, * American Society of Anesthesiologists (ASA) physical status 3 or 4, * heart failure, diabetes, * chronic respiratory disease, * obesity (BMI ≥30 kg/m2), * vascular disease, * preoperative haemoglobin \<100 g/L, * renal impairment (se. creatinine ≥150 micromol/L), or low albumin (\<30 g/L). * Written informed consent will be obtained. Exclusion criteria * Poor spoken and/or written language comprehension, * laparoscopic and other minor (eg. closure of stoma) surgery, * pre-existing infection/sepsis, * history of spontaneous pulmonary embolism or arterial thrombosis, * current arterial or venous thrombosis, * familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden), * contraindication to TxA.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-12-31