Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery

Anesthesia Clinical Trial

— TRIGS  

Official title:

Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery; The TRIGS Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04192435
• Other study ID #: 087
• Status: Recruiting
• Phase: Phase 4
• Start date: May 18, 2022
• Est. completion date: January 31, 2026

Study information

• Verified date: January 2023
• Source: Bayside Health
• Contact: Paul S Myles, MD, DSc
• Phone: +61390763176
• Email: p.myles[@]alfred.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 3300
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia
• Bleeding
• Communicable Diseases
• Cross Infection
• Gastrointestinal Complication
• Healthcare Associated Infection
• Infection Wound
• Infections

Intervention

Drug:
• Tranexamic Acid
100mg/ml
• Placebos
Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug.

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Bayside Health	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Surgical Site Infection	defined by the US Centers for Disease Control (CDC)	from surgical incision to 30 days post surgical incision
Secondary	Red cell transfusion	Total units given	from surgical incision to hospital discharge (from index surgery) or 30 days.
Secondary	Other healthcare-associated infections	sepsis, pneumonia, blood stream infection, UTI, etc; all using CDC-guided definitions	from surgical incision to 30 days
Secondary	C-reactive protein	peak	Postoperative Day 3 (three days after surgical incision)
Secondary	Days at home up to 30 days after surgery (DAH30).	Time that patient spends at home in the 30 days following surgery	From surgical incision to 30 days