Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery

Launched by BAYSIDE HEALTH · Dec 8, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called Tranexamic Acid (TxA) can help reduce the risk of infections after gastrointestinal (GI) surgery. The trial will include about 3,300 adult patients from Australia and other countries who are having major GI surgeries, such as operations on the esophagus, stomach, or intestines. To participate, patients need to be between the ages of 65 and 74 or younger than 36, and they should have certain health risk factors, like being over 70, having heart or breathing issues, being obese, or having low levels of hemoglobin (the protein in blood that carries oxygen).

Participants in this trial will receive either TxA or a placebo (a similar-looking substance that does not contain the medication) for comparison. The study is designed to reflect real-world medical practices, which means doctors will use their judgment when caring for patients during the trial. Patients will be monitored closely for any effects of the medication and to see if it helps in preventing infections after surgery. It’s important for potential participants to understand that this trial is focused on improving patient outcomes in surgery, especially for those at higher risk of complications.

Gender

ALL

Eligibility 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)