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

Launched by BAYSIDE HEALTH · Jul 20, 2022

Keywords

ClinConnect Summary

The TRIGS-D Trial is a clinical study that is investigating whether a medication called Tranexamic Acid (TxA) can help reduce the risk of delirium after major gastrointestinal surgery. Delirium is a sudden change in mental state that can occur after surgery, especially in older adults or those with certain health issues. This trial is looking for adult patients who are scheduled for specific types of gastrointestinal surgeries and have at least two risk factors for complications, such as being 70 years or older, having heart disease, diabetes, or obesity.

If you or a loved one is eligible and chooses to participate, you will receive either the TxA treatment or a placebo (a harmless substance with no active medicine) during your surgery. The researchers want to see if TxA can lower the chances of experiencing delirium afterward. The trial is currently recruiting participants, and your safety and well-being will be prioritized throughout the process. If you have any concerns or questions about your eligibility, it’s important to discuss them with your healthcare provider.

Gender

ALL

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.