Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery
- Conditions
- Gastrointestinal ComplicationInfection WoundHealthcare Associated InfectionBleedingAnesthesia
- Interventions
- Drug: Placebos
- Registration Number
- NCT04192435
- Lead Sponsor
- Bayside Health
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3300
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebos 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. Tranexamic acid 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.
- Primary Outcome Measures
Name Time Method Incidence of Surgical Site Infection from surgical incision to 30 days post surgical incision defined by the US Centers for Disease Control (CDC)
- Secondary Outcome Measures
Name Time Method C-reactive protein Postoperative Day 3 (three days after surgical incision) peak
Red cell transfusion from surgical incision to hospital discharge (from index surgery) or 30 days. Total units given
Other healthcare-associated infections from surgical incision to 30 days sepsis, pneumonia, blood stream infection, UTI, etc; all using CDC-guided definitions
Days at home up to 30 days after surgery (DAH30). From surgical incision to 30 days Time that patient spends at home in the 30 days following surgery
Trial Locations
- Locations (1)
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia