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Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D 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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-11-01
Primary completion: 2025-12-30
Study completion finish: 2025-12-31
Study type
PREVENTION
Phase
PHASE3
Trial ID
NCT05470816
Intervention or treatment
DRUG: Tranexamic Acid 100Mg/ml Inj Vial 10ml
DRUG: Placebo
Conditions
- • Dementia
- • Surgical Site Infection
- • Cognition
Find a site
Closest Location:
Alfred Health
Research sites nearby
Select from list below to view details:
Alfred Health
Melbourne, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Tranexamic Acid
| DRUG: Tranexamic Acid 100Mg/ml Inj Vial 10ml
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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 | post surgical incision to day 3 (at anytime)obtaining information from the patient, family and staff, and thorough chart review |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Delirium severity | 3D-CAM-S | 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 | 12 months post surgical incision |
| Disability | World Health Organization disability assessment schedule. Intergroup differences in long-term (12 month) in perioperative cognitive decline | 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). | 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). | 30 days post surgical incision post surgical incision |
| cytokine levels | Blood tests measured in 92 key inflammatory/immune markers using technology | 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 | preoperative, postoperative day 1 and 3 post surgical incision |
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