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

INTERVENTION: Intravenous Tranexamic Acid (1 gm in 10 ml) or Placebo (0.9% saline, 10 mls), administered twice daily for 4 days CONDITION: Infection ‐ Studies of infection and infectious agents Necrotising soft‐tissue infection ; ; Necrotising soft‐tissue infection PRIMARY OUTCOME: A reduction in the extent of NSTI at least 25% (within 95% CI of median total area measured by the treating surgical team)[During the index hospitalisation, or up to 30 days post‐admission (whichever is shorter).] 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. [; 30 Days follow up] SECONDARY OUTCOME: 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[up to 30 days post‐randomisation] Number of hyperbaric treatments, reported in the medical record and collected on the trial case report form[30 days post‐randomisation] Number of surgical debridements (original, plus reoperations), reported in the medical record and collected on the trial case report form[30 days post‐randomisation] Peak C‐reactive protein concentration, reported in the medical record and collected on the trial case report form[Day 3 post‐randomisation] 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[30 days post‐randomisation] Ventilator‐free days, reported in the medical record and collected on the trial case report form[30 days post‐randomisation] 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)