Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery (TRIGS)

Bayside Health

Status and phase: Completed; Phase 4

Conditions: Healthcare Associated Infection; Gastrointestinal Complication; Infection Wound; Bleeding; Anesthesia

Treatments: Drug: Tranexamic Acid; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT04192435

087

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,300 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,300 participants in 2 patient groups, including a placebo group

Tranexamic acid

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebos