Infection WoundPhase 4TRIGSNCT04192435
Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery
A Phase 4 study testing Tranexamic Acid in people with Infection Wound and Gastrointestinal Complication, run by Bayside Health at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Infection Wound, Gastrointestinal Complication, Anesthesia
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,300 participants
- Where
- 1 siteAustralia
- Study dates
- 18 May 2022to 20 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery; The TRIGS Trial
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.
Read the 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.
- Conditions
- Infection Wound, Gastrointestinal Complication, Anesthesia, Bleeding, Healthcare Associated Infection
- Being tested
- Tranexamic Acid, Placebos
- Medical subject headings
- Wound Infection, Hemorrhage, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
100mg/ml
PlacebosDrug
Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Surgical Site Infection
defined by the US Centers for Disease Control (CDC)
Measured: from surgical incision to 30 days post surgical incision
Secondary outcomes (4)
Red cell transfusion
Total units given
Measured: 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
Measured: from surgical incision to 30 days
C-reactive protein
peak
Measured: 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
Measured: From surgical incision to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start18 May 2022
- Primary completion13 Sep 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infection WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, placebo-controlled, randomised trial of TxA versus placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Sponsor
- Investigators
- Paul S Myles, MD, DSc, Study chair, Alfred Hospital and Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192435
- Sponsor's protocol ID
- 087
- Acronym
- TRIGS
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2019
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This decision will be made on a individual case by case basis, with formal request and review by the PI and steering committee.
Publications
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.
PubMed 31126915Bell 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.
PubMed 31317130
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery; The TRIGS Trial
- ClinicalTrials.gov ID
- NCT04192435
- Acronym / sponsor ID
- TRIGS / 087
- Conditions
- Infection Wound, Gastrointestinal Complication, Anesthesia, Bleeding, Healthcare Associated Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,300 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- 18 May 2022 (actual)
- Primary completion
- 13 Sep 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind, placebo-controlled, randomised trial of TxA versus placebo
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Active comparator | Drug: Tranexamic AcidAt 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. |
| Placebo | Placebo comparator | Drug: PlacebosAt 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid100mg/ml | Drug | Tranexamic acid |
| PlacebosPlacebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug. | Drug | Placebo |
Primary outcome
Incidence of Surgical Site Infection
Time frame: from surgical incision to 30 days post surgical incision
defined by the US Centers for Disease Control (CDC)
4 secondary outcomes
Red cell transfusion
Time frame: from surgical incision to hospital discharge (from index surgery) or 30 days.
Other healthcare-associated infections
Time frame: from surgical incision to 30 days
C-reactive protein
Time frame: Postoperative Day 3 (three days after surgical incision)
Days at home up to 30 days after surgery (DAH30).
Time frame: From surgical incision to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Background: PubMed 31126915Draxler 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.
- Background: PubMed 31317130Bell 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.
- Individual participant dataSharing planned: Yes. This decision will be made on a individual case by case basis, with formal request and review by the PI and steering committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul S Myles, MD, DSc study chair
Alfred Hospital and Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid in people with Infection Wound and Gastrointestinal Complication, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Surgical Site Infection (time frame: from surgical incision to 30 days post surgical incision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04192435, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.