Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery

NCT04192435 | Completed Phase 4 DMC

• 1 other identifier: 087
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Surgical Site Infection

  defined by the US Centers for Disease Control (CDC)

  from surgical incision to 30 days post surgical incision

Secondary Outcomes (4)

• Red cell transfusion

  from surgical incision to hospital discharge (from index surgery) or 30 days.

• Other healthcare-associated infections

  from surgical incision to 30 days

• C-reactive protein

  Postoperative Day 3 (three days after surgical incision)

• Days at home up to 30 days after surgery (DAH30).

  From surgical incision to 30 days

Study Arms (2)

Tranexamic acid

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Tranexamic Acid DRUG

100mg/ml

Tranexamic acid

Placebos DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayside Health: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Publications (2)

• Draxler DF, Yep K, Hanafi G, Winton A, Daglas M, Ho H, Sashindranath M, Wutzlhofer LM, Forbes A, Goncalves I, Tran HA, Wallace S, Plebanski M, Myles PS, Medcalf RL. Tranexamic acid modulates the immune response and reduces postsurgical infection rates. Blood Adv. 2019 May 28;3(10):1598-1609. doi: 10.1182/bloodadvances.2019000092.

  PMID: 31126915 BACKGROUND

• Bell M, Eriksson LI, Svensson T, Hallqvist L, Granath F, Reilly J, Myles PS. Days at Home after Surgery: An Integrated and Efficient Outcome Measure for Clinical Trials and Quality Assurance. EClinicalMedicine. 2019 Apr 27;11:18-26. doi: 10.1016/j.eclinm.2019.04.011. eCollection 2019 May-Jun.

  PMID: 31317130 BACKGROUND

MeSH Terms

Conditions

Wound Infection; Hemorrhage; Cross Infection

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Iatrogenic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Paul S Myles, MD, DSc

  Alfred Hospital and Monash University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Matched TxA and placebo vials
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: double-blind, placebo-controlled, randomised trial of TxA versus placebo

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 10, 2019
• Study Start: May 18, 2022
• Primary Completion: September 13, 2025
• Study Completion: October 20, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before recruitment of final patient
• Access Criteria: Patient and illness eligibility

Locations

AU (1)