Using Tranexamic Acid to Prevent Delirium After Gastrointestinal Surgery
Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial (a Substudy of the TRIGS Trial)
This study is testing if giving tranexamic acid can help prevent delirium in patients after major gastrointestinal surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 826 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Bayside Health Government |
| Locations | 2 sites (Melbourne, Victoria and 1 other locations) |
| Trial ID | NCT05470816 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of tranexamic acid (TxA) on reducing the incidence and severity of postoperative delirium in patients undergoing major gastrointestinal surgery. It aims to evaluate whether TxA can modulate inflammatory responses and improve long-term quality of life for patients at risk of delirium. The study will involve a subset of 826 patients from the larger TRIGS trial, comparing outcomes between those receiving TxA and a placebo. Key assessments will include the incidence of delirium diagnosed with the 3D-CAM and its severity measured with the 3D-CAM-Severity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 70 or older scheduled for elective gastrointestinal surgery with multiple risk factors for complications.
Not a fit: Patients undergoing minor surgeries or those with contraindications to tranexamic acid will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the occurrence of delirium and improve cognitive outcomes for patients after surgery.
How similar studies have performed: While there is growing evidence supporting the use of TxA in reducing inflammation, this specific application for preventing postoperative delirium is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Melbourne, Victoria and 1 other locations
- Alfred Health — Melbourne, Victoria, Australia (Recruiting)
- Alfred Health — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Paul S Myles, DSci
- Email: p.myles@alfred.org.au
- Phone: +61390763176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.