RecruitingPhase 3Phase 4ACTRN12621001423808

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


Sponsor

The Alfred

Enrollment

60 participants

Start Date

Nov 15, 2021

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Necrotising soft tissue infections (NSTIs) — sometimes called 'flesh-eating infections' — are a rare but life-threatening type of deep tissue infection that spreads rapidly and requires urgent surgery to remove affected tissue. This pilot study is testing whether a medication called tranexamic acid (TXA), already commonly used to reduce blood loss in surgery and trauma, might help slow the spread of these devastating infections. TXA is thought to work in NSTI by reducing the breakdown of fibrin — a protein that forms a natural barrier against infection spread. The trial gives intravenous TXA or a placebo twice daily for four days to patients hospitalised with a suspected NSTI. The primary goal is to find out whether a larger definitive trial would be feasible, based on consent rates, treatment completion, and early signs that TXA limits infection spread. This study is open to adults aged 18 and older who have been admitted to hospital with a suspected NSTI and have not yet had their first definitive surgical debridement. People with active blood clots, a personal or family history of spontaneous blood clots, or colour blindness would not be eligible for this trial.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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


Locations(3)

The Alfred - Melbourne

NSW,NT,VIC, Australia

Prince of Wales Private Hospital - Randwick

NSW,NT,VIC, Australia

Royal Darwin Hospital - Tiwi

NSW,NT,VIC, Australia

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ACTRN12621001423808