Surgical Site InfectionPhase 3TRIGS-DNCT05470816
Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial
A Phase 3 study testing Tranexamic Acid 100Mg/ml Inj Vial 10ml in people with Surgical Site Infection and Dementia, run by Bayside Health at 1 site in Australia.
Trial summary
Prophylactic TxA administration in patients undergoing major gastrointestinal surgery reduces the incidence of delirium after surgery when compared with placebo. The unifying hypothesis is that systemic and neuro-inflammation lead to neuronal injury and resultant postoperative delirium. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Surgical Site Infection, Dementia, Cognition
- What is being tested?
- Tranexamic Acid 100Mg/ml Inj Vial 10ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 826 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Nov 2022to 31 Aug 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled for elective gastrointestinal (oesophageal, gastric, hepatobiliary, colorectal) surgery
- with 2 or more risk factors for complications:
- age ≥70 years,
- American Society of Anesthesiologists (ASA) physical status 3 or 4,
- heart failure, diabetes,
- chronic respiratory disease,
Show all 18Show fewer
- obesity (BMI ≥30 kg/m2),
- vascular disease,
- preoperative haemoglobin <100 g/L,
- renal impairment (se. creatinine ≥150 micromol/L), or low albumin (<30 g/L).
- Written informed consent will be obtained. Exclusion criteria
- Poor spoken and/or written language comprehension,
- laparoscopic and other minor (eg. closure of stoma) surgery,
- pre-existing infection/sepsis,
- history of spontaneous pulmonary embolism or arterial thrombosis,
- current arterial or venous thrombosis,
- familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden),
- contraindication to TxA.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial (a Substudy of the TRIGS Trial)
Prophylactic TxA administration in patients undergoing major gastrointestinal surgery reduces the incidence of delirium after surgery when compared with placebo. The unifying hypothesis is that systemic and neuro-inflammation lead to neuronal injury and resultant postoperative delirium.
Read the detailed description
Delirium is a devastating complication of medical and perioperative care, associated with increased morbidity and mortality, dementia and impaired long-term cognition, and loss of independence. Delirium is also associated with neuronal injury placing patients at risk for long-term changes in cognition. There are no proven therapies for postoperative delirium, mainly due to the lack of adequately powered, biologically plausible trials.
There is growing evidence that tranexamic acid (TxA) may reduce inflammatory pathways in the central nervous system and protect the blood-brain barrier in trauma, and surgery.
This sub-study of the TRIGS trial (www.trigs.com.au) is evaluating the potential impact of TxA on the incidence and severity of delirium after surgery.
TRIGS-D Study Aims: In a subset of 826 patients enrolled in the TRIGS randomized trial data will be collected to identify delirium incidence and severity. The specific aims are to investigate whether TxA:
Aim 1: Reduces the incidence of postoperative delirium diagnosed with the 3D-CAM.
Aim 2: Reduces the severity of delirium diagnosed with the 3D-CAM-Severity (3D-CAM-S).
Aim 3: Modulates inflammatory (plasma cytokines, innate cell immune profile) and neurophysiological (EEG) responses in concert with any alteration in the incidence or severity of delirium.
Aim 4: Reduces longer-term impairment of quality of life and improves disability-free survival.
Primary hypothesis: Prophylactic TxA administration in patients undergoing major gastrointestinal surgery reduces the incidence of delirium after surgery when compared with placebo. The unifying hypothesis is that systemic and neuro-inflammation lead to neuronal injury and resultant postoperative delirium.
Study Design: Multicentre, randomized, triple-blind, placebo-controlled, clinical trial (a sub-study of the TRIGS trial). Patients are randomly assigned to either TxA or matched placebo. The incidence of postoperative delirium will be assessed daily using the 3D-CAM or CAM-ICU and medical record review for the first 3 days after surgery. In addition, follow up assessments will be done at 30 days and 12 months.
- Conditions
- Surgical Site Infection, Dementia, Cognition
- Being tested
- Tranexamic Acid 100Mg/ml Inj Vial 10ml, Placebo
- Medical subject headings
- Surgical Wound Infection, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid 100Mg/ml Inj Vial 10mlDrug
Also called Cyklokapron
Intervention is from the Tranexamic acid to Reduce Infection after Gastrointestinal Surgery: the TRIGS Trial. A multicentre, pragmatic, double-blind, randomised clinical trial will compare the incidence of surgical site infection and red cell transfusion requirements after IV tranexamic acid and placebo in patients undergoing gastrointestinal surgery
PlaceboDrug
Also called Normal Saline
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Active comparator | 12 mg/kg, before surgical incision, and then an infusion of 3 mg/kg/h until the end of surgery. Receives: Drug: Tranexamic Acid 100Mg/ml Inj Vial 10ml |
| Placebo | Placebo comparator | 12 mg/kg, before surgical incision, and then an infusion of 3 mg/kg/h until the end of surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of delirium in the first 3 days postoperatively
3D-Confusion Assessment Method (3D-CAM) or CAM-ICU if the Used to measure delirium. Assessments will be conducted twice daily A classification of delirium will be made if both features 1 and 2 are present
Measured: post surgical incision to day 3 (at anytime)obtaining information from the patient, family and staff, and thorough chart review
Secondary outcomes (7)
Delirium severity
3D-CAM-S
Measured: post surgical incision to day 3 (inclusive)
Quality of Life Intergroup differences
using the Short form survey 12 - Quality of Life Intergroup differences in long-term (12 month) in perioperative cognitive decline
Measured: 12 months post surgical incision
Disability
World Health Organization disability assessment schedule. Intergroup differences in long-term (12 month) in perioperative cognitive decline
Measured: 12 months post surgical incision
perioperative neurocognitive disorders (NCDs)
NCD will be defined as any of: (i) subjective complaint, (ii) a 4-point reduction in TICS-B, (iii) SF or VF, and (iv) functional deficit defined as a reduction in WHODAS score of 5% or more from baseline (before surgery).
Measured: 12 months post surgical incision
Days at home up to 30 days after surgery (DAH30)
DAH30 is patient-centred and reflects the patient's primary aim of a healthy recovery, reduced hospital costs and serious complications, and avoiding re-admission (often due to postoperative delirium).
Measured: 30 days post surgical incision post surgical incision
cytokine levels
Blood tests measured in 92 key inflammatory/immune markers using technology
Measured: preoperative, postoperative day 1 and 3 post surgical incision
neuronal injury biomarker
used to evaluate temporal changes in the innate cellular immune and inflammatory profile, and for changes in fibrinolysis
Measured: preoperative, postoperative day 1 and 3 post surgical incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start1 Nov 2022
- Primary completion13 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, randomised, triple-blind, placebo-controlled, clinical trial (a substudy of the TRIGS trial).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 826 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Monash University
- Responsible party
- Sponsor
- Investigators
- Paul S Myles, DSci, Study chair, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470816
- Sponsor's protocol ID
- 58/20
- Acronym
- TRIGS-D
- Status last verified
- Dec 2025
- First submitted
- 5 Jul 2022
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following written request and review by the steering committee
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 Delirium After Gastrointestinal Surgery: the TRIGS-D Trial (a Substudy of the TRIGS Trial)
- ClinicalTrials.gov ID
- NCT05470816
- Acronym / sponsor ID
- TRIGS-D / 58/20
- Conditions
- Surgical Site Infection, Dementia, Cognition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 826 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Monash University
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 13 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 22 Jul 2022 (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.
Prophylactic TxA administration in patients undergoing major gastrointestinal surgery reduces the incidence of delirium after surgery when compared with placebo. The unifying hypothesis is that systemic and neuro-inflammation lead to neuronal injury and resultant postoperative delirium.
Detailed description
Delirium is a devastating complication of medical and perioperative care, associated with increased morbidity and mortality, dementia and impaired long-term cognition, and loss of independence. Delirium is also associated with neuronal injury placing patients at risk for long-term changes in cognition. There are no proven therapies for postoperative delirium, mainly due to the lack of adequately powered, biologically plausible trials.
There is growing evidence that tranexamic acid (TxA) may reduce inflammatory pathways in the central nervous system and protect the blood-brain barrier in trauma, and surgery.
This sub-study of the TRIGS trial (www.trigs.com.au) is evaluating the potential impact of TxA on the incidence and severity of delirium after surgery.
TRIGS-D Study Aims: In a subset of 826 patients enrolled in the TRIGS randomized trial data will be collected to identify delirium incidence and severity. The specific aims are to investigate whether TxA:
Aim 1: Reduces the incidence of postoperative delirium diagnosed with the 3D-CAM.
Aim 2: Reduces the severity of delirium diagnosed with the 3D-CAM-Severity (3D-CAM-S).
Aim 3: Modulates inflammatory (plasma cytokines, innate cell immune profile) and neurophysiological (EEG) responses in concert with any alteration in the incidence or severity of delirium.
Aim 4: Reduces longer-term impairment of quality of life and improves disability-free survival.
Primary hypothesis: Prophylactic TxA administration in patients undergoing major gastrointestinal surgery reduces the incidence of delirium after surgery when compared with placebo. The unifying hypothesis is that systemic and neuro-inflammation lead to neuronal injury and resultant postoperative delirium.
Study Design: Multicentre, randomized, triple-blind, placebo-controlled, clinical trial (a sub-study of the TRIGS trial). Patients are randomly assigned to either TxA or matched placebo. The incidence of postoperative delirium will be assessed daily using the 3D-CAM or CAM-ICU and medical record review for the first 3 days after surgery. In addition, follow up assessments will be done at 30 days and 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, randomised, triple-blind, placebo-controlled, clinical trial (a substudy of the TRIGS trial).
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Active comparator | Drug: Tranexamic Acid 100Mg/ml Inj Vial 10ml12 mg/kg, before surgical incision, and then an infusion of 3 mg/kg/h until the end of surgery. |
| Placebo | Placebo comparator | Drug: Placebo12 mg/kg, before surgical incision, and then an infusion of 3 mg/kg/h until the end of surgery. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Adult patients scheduled for elective gastrointestinal (oesophageal, gastric, hepatobiliary, colorectal) surgery
- with 2 or more risk factors for complications:
- age ≥70 years,
- American Society of Anesthesiologists (ASA) physical status 3 or 4,
- heart failure, diabetes,
Key exclusion criteria (0 listed)
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 Acid 100Mg/ml Inj Vial 10mlAlso: CyklokapronIntervention is from the Tranexamic acid to Reduce Infection after Gastrointestinal Surgery: the TRIGS Trial. A multicentre, pragmatic, double-blind, randomised clinical trial will compare the incidence of surgical site infection and red cell transfusion requirements after IV tranexamic acid and placebo in patients undergoing gastrointestinal surgery | Drug | Tranexamic Acid |
| PlaceboAlso: Normal SalineNormal saline | Drug | Placebo |
Primary outcome
incidence of delirium in the first 3 days postoperatively
Time frame: post surgical incision to day 3 (at anytime)obtaining information from the patient, family and staff, and thorough chart review
3D-Confusion Assessment Method (3D-CAM) or CAM-ICU if the Used to measure delirium. Assessments will be conducted twice daily A classification of delirium will be made if both features 1 and 2 are present
7 secondary outcomes
Delirium severity
Time frame: post surgical incision to day 3 (inclusive)
Quality of Life Intergroup differences
Time frame: 12 months post surgical incision
Disability
Time frame: 12 months post surgical incision
perioperative neurocognitive disorders (NCDs)
Time frame: 12 months post surgical incision
Days at home up to 30 days after surgery (DAH30)
Time frame: 30 days post surgical incision post surgical incision
cytokine levels
Time frame: preoperative, postoperative day 1 and 3 post surgical incision
neuronal injury biomarker
Time frame: preoperative, postoperative day 1 and 3 post surgical incision
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes. Following written request and review by the 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, DSci study chair
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 3 study testing Tranexamic Acid 100Mg/ml Inj Vial 10ml in people with Surgical Site Infection and Dementia, 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 18 inclusion and 0 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: under way, not looking for participants, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 delirium in the first 3 days postoperatively (time frame: post surgical incision to day 3 (at anytime)obtaining information from the patient, family and staff, and thorough chart review). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.