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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04192435




Registration number
NCT04192435
Ethics application status
Date submitted
27/11/2019
Date registered
10/12/2019
Date last updated
11/01/2023

Titles & IDs
Public title
Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery
Scientific title
Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery; The TRIGS Trial
Secondary ID [1] 0 0
087
Universal Trial Number (UTN)
Trial acronym
TRIGS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection Wound 0 0
Gastrointestinal Complication 0 0
Anesthesia 0 0
Bleeding 0 0
Healthcare Associated Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tranexamic Acid
Treatment: Drugs - Placebos

Active comparator: Tranexamic acid - 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.

Placebo comparator: Placebo - 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.


Treatment: Drugs: Tranexamic Acid
100mg/ml

Treatment: Drugs: Placebos
Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Surgical Site Infection
Timepoint [1] 0 0
from surgical incision to 30 days post surgical incision
Secondary outcome [1] 0 0
Red cell transfusion
Timepoint [1] 0 0
from surgical incision to hospital discharge (from index surgery) or 30 days.
Secondary outcome [2] 0 0
Other healthcare-associated infections
Timepoint [2] 0 0
from surgical incision to 30 days
Secondary outcome [3] 0 0
C-reactive protein
Timepoint [3] 0 0
Postoperative Day 3 (three days after surgical incision)
Secondary outcome [4] 0 0
Days at home up to 30 days after surgery (DAH30).
Timepoint [4] 0 0
From surgical incision to 30 days

Eligibility
Key inclusion criteria
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)
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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)

Study design
Purpose of the study
Treatment
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 4
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
18/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
3300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04192435
Trial related presentations / 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.
Bell 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.
Public notes

Contacts
Principal investigator
Name 0 0
Paul S Myles, MD, DSc
Address 0 0
Alfred Hospital and 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, MD, DSc
Address 0 0
Country 0 0
Phone 0 0
+61390763176
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04192435