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Trial registered on ANZCTR


Registration number
ACTRN12621001423808
Ethics application status
Approved
Date submitted
8/09/2021
Date registered
21/10/2021
Date last updated
4/10/2022
Date data sharing statement initially provided
21/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Feasibility Trial of Tranexamic Acid for Necrotising Soft-tissue Infections
Scientific title
A Feasibility Trial of Tranexamic Acid for Necrotising Soft-tissue Infections
Secondary ID [1] 305254 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
TRITON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Necrotising soft-tissue infection 323528 0
Condition category
Condition code
Infection 321090 321090 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous Tranexamic Acid (1 gm in 10 ml) or Placebo (0.9% saline, 10 mls), administered twice daily for 4 days
Intervention code [1] 321645 0
Treatment: Drugs
Comparator / control treatment
0.9% saline, 10 ml, at each dose administration (twice daily on day of admission, then for 4 days)
Control group
Placebo

Outcomes
Primary outcome [1] 328871 0
Feasibility of a randomised trial evaluating tranexamic acid for the treatment of necrotising soft-tissue infection (NSTI) will be defined by all of the following:
(i) The proportion of eligible participants (patient/family member) identified in the enrolment log consenting is at least 40%
(ii) Study drug administration compliance is at least 80%, confirmed by the research coordinator with the clinicians and (electronic, if available) pharmacy record
(iii) The incidence or reported serious study drug-related adverse events is less than 5% higher (absolute) compared with the placebo group, detected by clinicians and documented in the medical record. These events are prespecified as seizures, myocardial infarction, stroke and pulmonary embolism.
Timepoint [1] 328871 0

30 Days follow up
Primary outcome [2] 329092 0
A reduction in the extent of NSTI at least 25% (within 95% CI of median total area measured by the treating surgical team)
Timepoint [2] 329092 0
During the index hospitalisation, or up to 30 days post-admission (whichever is shorter).
Secondary outcome [1] 400687 0
Number of surgical debridements (original, plus reoperations), reported in the medical record and collected on the trial case report form
Timepoint [1] 400687 0
30 days post-randomisation
Secondary outcome [2] 400688 0
Number of hyperbaric treatments, reported in the medical record and collected on the trial case report form
Timepoint [2] 400688 0
30 days post-randomisation
Secondary outcome [3] 400689 0
Peak C-reactive protein concentration, reported in the medical record and collected on the trial case report form
Timepoint [3] 400689 0
Day 3 post-randomisation
Secondary outcome [4] 400690 0
Ventilator-free days, reported in the medical record and collected on the trial case report form
Timepoint [4] 400690 0
30 days post-randomisation
Secondary outcome [5] 400691 0
The Necrotizing Infection Clinical Composite Endpoint (NICCE), defined as follows: (i) alive at day 28, (ii) three or less debridements before day 14, (iii) no amputation beyond first debridement, (iv) modified sequential organ failure assessment score score (mSOFA) at day 14 = 1. These data will be abstracted from the medical record and collected on the trial case report form
Timepoint [5] 400691 0
30 days post-randomisation
Secondary outcome [6] 400692 0
Number of days alive and at home (DAH30), reported in the medical record and/or via telephone follow-up with participants who have been discharged before 30 days post-randomisation, and collected on the trial case report form
Timepoint [6] 400692 0
up to 30 days post-randomisation

Eligibility
Key inclusion criteria
Adults (18 years or older) admitted to hospital with a suspected diagnosis of NSTI and not yet undergone definitive surgical debridement (as determined by the local surgical team)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient or medical treatment decision maker (MTDM) refusal
2. Previous surgical debridement of current infected tissue – this does not include a local incision or biopsy
3. Current deep vein thrombosis or pulmonary embolism
4. Known history of unprovoked (spontaneous) pulmonary embolism or arterial thrombosis, or familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden)
5. History of colour blindness

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)
central randomisation by REDCAP
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible patients will be randomly assigned from a computer-generated list (1:1), stratified by centre, to either TxA or placebo groups.
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 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive data will be presented as no. (%), mean (SD), or median (IQR). Non-Normal numerical data will be bootstrapped and reported as mean (95% CI). Exploratory analyses will be done, comparing groups with t-tests (if Normal) or Mann-Whitney U tests, and differences expressed as 95% CI. We plan to report and publish this pilot trial according to the CONSORT 2010 statement

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/11/2021
Actual
Date of last participant enrolment
Anticipated
15/11/2022
Actual
Date of last data collection
Anticipated
15/12/2022
Actual
Sample size
Target
60
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,VIC
Recruitment hospital [1] 20486 0
The Alfred - Melbourne
Recruitment hospital [2] 20487 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [3] 20488 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 35258 0
3004 - Melbourne
Recruitment postcode(s) [2] 35259 0
2031 - Randwick
Recruitment postcode(s) [3] 35260 0
0810 - Tiwi

Funding & Sponsors
Funding source category [1] 309623 0
University
Name [1] 309623 0
Monash University
Country [1] 309623 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
55 Commercial Road, Melbourne, Vic 3004
Country
Australia
Secondary sponsor category [1] 310642 0
None
Name [1] 310642 0
Address [1] 310642 0
Country [1] 310642 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309398 0
The Alfred ethics committee
Ethics committee address [1] 309398 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 309398 0
Australia
Date submitted for ethics approval [1] 309398 0
28/10/2021
Approval date [1] 309398 0
28/10/2021
Ethics approval number [1] 309398 0

Summary
Brief summary
The primary aim of this pilot trial is to determine whether a larger definitive trial is worthwhile and feasible. Success will be defined by all of the following:
(i) A patient/family member consent rate at least 40%
(ii) Complete study drug administration at least 80%
(iii) A reduction in the extent of NSTI at least 25% (within 95% CI of median total area)
(iv) Serious study drug-related adverse events less than 5%.


Study Hypotheses
(i) Feasibility – A multicentre randomised trial evaluating tranexamic acid (TxA) in necrotising soft-tissue infections (NSTI) is feasible
(ii) Clinical efficacy - TxA administration in patients admitted to hospital with a suspected diagnosis of NSTI reduces the spread of tissue infection when compared with placebo.


Methods
This multicentre, double-blind, parallel group, randomised trial will enrol 60 patients admitted to hospital with a diagnosis of NSTI. We will evaluate intravenous TxA, 1 gm, administered twice daily for 4 days.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114014 0
Prof Paul Myles
Address 114014 0
Department of Anaesthesiology and Perioperative Medicine
Alfred Hospital
55 Commercial Road
Melbourne
Victoria, 3004
Country 114014 0
Australia
Phone 114014 0
+61 390763176
Fax 114014 0
+61 390768076
Email 114014 0
[email protected]
Contact person for public queries
Name 114015 0
Paul Myles
Address 114015 0
Department of Anaesthesiology and Perioperative Medicine
Alfred Hospital
55 Commercial Road
Melbourne
Victoria, 3004
Country 114015 0
Australia
Phone 114015 0
+61 390763176
Fax 114015 0
+61 390768076
Email 114015 0
[email protected]
Contact person for scientific queries
Name 114016 0
Paul Myles
Address 114016 0
Department of Anaesthesiology and Perioperative Medicine
Alfred Hospital
55 Commercial Road
Melbourne
Victoria, 3004
Country 114016 0
Australia
Phone 114016 0
+61 390763176
Fax 114016 0
+61 390768076
Email 114016 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Group, demographic, process and outcome data
When will data be available (start and end dates)?
Up to 5 years after publication of the pilot trial
Available to whom?
Researchers, following submission of a protocol and ethics approval (if needed)
Available for what types of analyses?
Meta-analysis or independent validation
How or where can data be obtained?
Request to Prof Paul Myles, [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.