Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Prophylactic TxA administration in patients undergoing major gastrointestinal surgery reduces the incidence of delirium after surgery when compared with placebo. The unifying hypothesis is that systemic and neuro-inflammation lead to neuronal injury and resultant postoperative delirium.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayside Health
• Collaborator: Monash University
• Treatments: Tranexamic Acid

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.