Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05470816




Registration number
NCT05470816
Ethics application status
Date submitted
5/07/2022
Date registered
22/07/2022
Date last updated
11/01/2023

Titles & IDs
Public title
Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial
Scientific title
Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial (a Substudy of the TRIGS Trial)
Secondary ID [1] 0 0
58/20
Universal Trial Number (UTN)
Trial acronym
TRIGS-D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical Site Infection 0 0
Dementia 0 0
Cognition 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Surgery 0 0 0 0
Other surgery
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tranexamic Acid 100Mg/ml Inj Vial 10ml
Treatment: Drugs - Placebo

Active Comparator: Tranexamic Acid - 12 mg/kg, before surgical incision, and then an infusion of 3 mg/kg/h until the end of surgery.

Placebo Comparator: Placebo - 12 mg/kg, before surgical incision, and then an infusion of 3 mg/kg/h until the end of surgery.


Treatment: Drugs: Tranexamic Acid 100Mg/ml Inj Vial 10ml
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

Treatment: Drugs: Placebo
Normal saline
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
incidence of delirium in the first 3 days postoperatively
Timepoint [1] 0 0
post surgical incision to day 3 (at anytime)obtaining information from the patient, family and staff, and thorough chart review
Secondary outcome [1] 0 0
Delirium severity
Timepoint [1] 0 0
post surgical incision to day 3 (inclusive)
Secondary outcome [2] 0 0
Quality of Life Intergroup differences
Timepoint [2] 0 0
12 months post surgical incision
Secondary outcome [3] 0 0
Disability
Timepoint [3] 0 0
12 months post surgical incision
Secondary outcome [4] 0 0
perioperative neurocognitive disorders (NCDs)
Timepoint [4] 0 0
12 months post surgical incision
Secondary outcome [5] 0 0
Days at home up to 30 days after surgery (DAH30)
Timepoint [5] 0 0
30 days post surgical incision post surgical incision
Secondary outcome [6] 0 0
cytokine levels
Timepoint [6] 0 0
preoperative, postoperative day 1 and 3 post surgical incision
Secondary outcome [7] 0 0
neuronal injury biomarker
Timepoint [7] 0 0
preoperative, postoperative day 1 and 3 post surgical incision

Eligibility
Key inclusion criteria
Inclusion criteria

- 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,

- 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.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
826
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05470816
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul S Myles, DSci
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul S Myles, DSci
Address 0 0
Country 0 0
Phone 0 0
+61390763176
Fax 0 0
Email 0 0
p.myles@alfred.org.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05470816