A Phase 3 interventional study of Tranexamic Acid 100Mg/ml Inj Vial 10ml and Placebo in Surgical Site Infection, Dementia and Cognition, sponsored by Bayside Health. Active, not recruiting at 1 site in Australia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Bayside Health · Phase 3, Interventional, and Prevention
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.
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.
670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.
This study's planned enrollment of 826 is above the median of 200 across 514 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Bayside Health is the lead sponsor of 110 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria
12 mg/kg, before surgical incision, and then an infusion of 3 mg/kg/h until the end of surgery.
Drug: Tranexamic Acid 100Mg/ml Inj Vial 10ml
12 mg/kg, before surgical incision, and then an infusion of 3 mg/kg/h until the end of surgery.
Drug: Placebo
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
Also known as: Cyklokapron
Normal saline
Also known as: Normal Saline
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
Time frame: post surgical incision to day 3 (at anytime)obtaining information from the patient, family and staff, and thorough chart review
Delirium severity
3D-CAM-S
Time frame: 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
Time frame: 12 months post surgical incision
Disability
World Health Organization disability assessment schedule. Intergroup differences in long-term (12 month) in perioperative cognitive decline
Time frame: 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).
Time frame: 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).
Time frame: 30 days post surgical incision post surgical incision
cytokine levels
Blood tests measured in 92 key inflammatory/immune markers using technology
Time frame: 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
Time frame: preoperative, postoperative day 1 and 3 post surgical incision
Plan to share: Yes — Following written request and review by the steering committee
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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