Anesthesia, Bleeding, Gastrointestinal Complication, Healthcare Associated Infection, Infection Wound
Conditions
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.
Interventions
DRUGTranexamic Acid
100mg/ml
DRUGPlacebos
Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug.
Sponsors
National Health and Medical Research Council, Australia
Bayside Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Matched TxA and placebo vials
Intervention model description
double-blind, placebo-controlled, randomised trial of TxA versus placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Surgical Site Infection | from surgical incision to 30 days post surgical incision | defined by the US Centers for Disease Control (CDC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| C-reactive protein | Postoperative Day 3 (three days after surgical incision) | peak |
| 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 |
Countries
Australia
Outcome results
None listed