Using Tranexamic Acid to Prevent Infections After Gastrointestinal Surgery
Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery; The TRIGS Trial
This study is testing if tranexamic acid can help prevent infections and complications in people having major gastrointestinal surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 3300 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Bayside Health Government |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT04192435 on ClinicalTrials.gov |
What this trial studies
This international, multicentre trial investigates the effectiveness of tranexamic acid (TxA) in reducing surgical site infections and other complications in 3,300 patients undergoing major gastrointestinal surgery. The study is designed as a double-blind, placebo-controlled trial, allowing for some flexibility in clinical practice to enhance generalizability. The primary aim is to determine if TxA can lower the incidence of infections and the need for blood transfusions, while also evaluating its impact on postoperative complications and patient recovery. The trial will also assess the drug's effects on immune and inflammatory responses during the perioperative period.
Who should consider this trial
Good fit: Ideal candidates include adults scheduled for elective or semi-elective major gastrointestinal surgery with specific risk factors for complications.
Not a fit: Patients undergoing minor surgeries or those with pre-existing infections or certain thrombosis conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of infections and improve recovery outcomes for patients undergoing major gastrointestinal surgery.
How similar studies have performed: Previous studies have shown promising results with tranexamic acid in reducing bleeding in other surgical contexts, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients scheduled for elective or semi-elective (inpatient) open or lap-assisted GI surgery (oesophageal, gastric, hepatobiliary, colorectal) with one or more risk factors for complications: * Age ≥70 years * ASA physical status 3 or 4 * Known or suspected history of: heart failure, diabetes, peripheral vascular disease, or chronic respiratory disease * Obesity (BMI ≥30 kg/m2) * Anaemia (preoperative haemoglobin \<130 g/l in males and \<120 g/l in females) * Renal impairment (se. creatinine ≥150mol/l) * Low albumin (\<30 g/L) Exclusion Criteria: * Poor spoken and or written language comprehension * Laparoscopic cholecystectomy and other minor (eg. closure of stoma) surgery * Pre-existing infection/sepsis * Known history of: spontaneous pulmonary embolism, arterial thrombosis familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden)
Where this trial is running
Melbourne, Victoria
- Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Paul S Myles, MD, DSc
- 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.