A Feasibility Trial of Tranexamic Acid for Necrotising Soft-tissue Infections

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621001423808

Acronym

TRITON

Enrollment

Registered

2021-10-21

Start date

2021-11-15

Completion date

2025-11-27

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

Intravenous Tranexamic Acid (1 gm in 10 ml) or Placebo (0.9% saline, 10 mls), administered twice daily for 4 days

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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)

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

Outcome results