Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery

  • End date
    Jan 31, 2026
  • participants needed
  • sponsor
    Bayside Health
Updated on 28 January 2021


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.


Study Aims: To conduct a large, multicentre clinical trial of tranexamic acid (TxA), an antifibrinolytic drug routinely used to reduce bleeding in cardiac and some orthopaedic surgery, in 3,300 patients undergoing major gastrointestinal (GI) surgery. Our specific aims are to investigate whether TxA:

Aim 1: Reduces surgical site infection ("wound infection"), and other healthcare-associated infections (pneumonia and sepsis).

Aim 2: Reduces red cell transfusion in GI surgery. Aim 3: Reduces a pooled composite of any serious postoperative complications, and so increases "days alive and at home up to 30 days after surgery" (DAH30).

Aim 4: To evaluate the temporal effect of TxA on perioperative immune and inflammatory responses.

Study Hypothesis Prophylactic TxA administration in patients undergoing major GI surgery reduces the incidence of surgical site infection (SSI) after surgery when compared with placebo.

Condition Hemorrhage, Hemorrhage, Wound Infection, dental anesthesia, Anesthesia, Anesthesia (Local), Anesthesia, Anesthesia (Local), Gastrointestinal Complications, Gastrointestinal Complication, Healthcare Associated Infection, nosocomial infection, sensory loss, healthcare-associated infection, anaesthesia, anesthesia for, anesthesia procedures
Treatment placebos, Tranexamic Acid
Clinical Study IdentifierNCT04192435
SponsorBayside Health
Last Modified on28 January 2021


Yes No Not Sure

Inclusion Criteria

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)
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