A Feasibility Trial of Tranexamic Acid for Necrotising Soft-tissue Infections
The Alfred
60 participants
Nov 15, 2021
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
Plain Language Summary
Simplified for easier understanding
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
Locations(3)
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ACTRN12621001423808