A Phase 4 interventional study of Tranexamic Acid and Placebos in Infection Wound, Gastrointestinal Complication and Anesthesia, sponsored by Bayside Health. Completed at 1 site in Australia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Bayside Health · Phase 4, Interventional, and Treatment
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.
382 studies on the registry are indexed under Wound Infection; 40 are open to participants now.
This study's enrollment of 3,300 is above the median of 150 across 296 interventional studies indexed under Wound Infection.
Browse Wound Infection studies →Bayside Health is the lead sponsor of 110 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml.
Drug: Tranexamic Acid
At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml.
Drug: Placebos
100mg/ml
Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug.
Incidence of Surgical Site Infection
defined by the US Centers for Disease Control (CDC)
Time frame: from surgical incision to 30 days post surgical incision
Red cell transfusion
Total units given
Time frame: from surgical incision to hospital discharge (from index surgery) or 30 days.
Other healthcare-associated infections
sepsis, pneumonia, blood stream infection, UTI, etc; all using CDC-guided definitions
Time frame: from surgical incision to 30 days
C-reactive protein
peak
Time frame: Postoperative Day 3 (three days after surgical incision)
Days at home up to 30 days after surgery (DAH30).
Time that patient spends at home in the 30 days following surgery
Time frame: From surgical incision to 30 days
Plan to share: Yes — This decision will be made on a individual case by case basis, with formal request and review by the PI and steering committee.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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