STOP-AUST: The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial "STOP-AUST"

Recruiting

Phase 2 Results N/A

Trial Description

The aim of the study is to test if intracerebral haemorrhage (ICH) patients who have contrast extravasation on computed tomography angiography, the "spot sign", have lower rates of haematoma growth when treated with tranexamic acid within 4.5 hours of stroke onset, compared to placebo.

Conditions

Interventions

  • Tranexamic Acid (Cyklokapron)Drug
    ARM 1: Kind: Experimental
    Label: Tranexamic Acid
    Description: Intravenous tranexamic acid 1000 mg in 100 mL 0.9% NaCl over 10 minutes followed by 1000 mg in 500 mL 0.9% NaCl infusion over 8 hours.
  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Intravenous placebo in 100 mL 0.9% NaCl over 10 minutes followed by 500 mL 0.9% NaCl infusion over 8 hours.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume. 24+/-3 hours No
Secondary Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism) Within 90+/-7 days Yes
Secondary Absolute ICH growth volume by 24±3 hours, adjusted for baseline ICH volume 24+/-3 hours No
Secondary Absolute intraventricular haematoma (IVH) growth volume by 24±3 hours, adjusted for baseline IVH volume 24+/-3 hours No
Secondary modified Rankin Scale (mRS) score of 0-4 at 3 months 90+/-7 days No
Secondary modified Rankin Scale (mRS) score of 0-3 at 3 months 90+/-7 days No
Secondary Categorical shift in mRS at 3 months, subject to the validity of proportional odds assumption 90+/-7 days No
Secondary Death due to any cause by 3 months within 90+/-7 days No

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