Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery

Phase 4CompletedNCT04192435

Bayside Health3,300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

3,300

Conditions

Infection Wound Gastrointestinal Complication Anesthesia Bleeding Healthcare Associated Infection

Interventions

Tranexamic AcidDRUG

100mg/ml

PlacebosDRUG

Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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)

Locations (1)

Alfred Hospital

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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