CompletedPhase 4

Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery

Australia3,300 participantsStarted 2022-05-18

Plain-language summary

This international, multicentre, pragmatic, double-blind, placebo-controlled, randomised trial of TxA versus placebo will enrol 3,300 patients throughout Australia and internationally. This is an effectiveness trial - some elements of the trial are deliberately left to the perioperative clinicians' discretion in order to reflect usual practice and maximise generalisability.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Incidence of Surgical Site Infection

Timeframe: from surgical incision to 30 days post surgical incision

Trial details

NCT IDNCT04192435

SponsorBayside Health

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-09-13

View on ClinicalTrials.gov More Infection Wound trials