Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign "TRAIGE"

Recruiting

Phase 2 Results N/A

Trial Description

The purpose of this study is to determine if computed tomography angiography can predict which individuals with intracerebral hemorrhage will experience significant growth in the size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the study will compare the drug Tranexamic acid to placebo to determine the effect and safety of on intracerebral hemorrhage growth

Detailed Description

The Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign (TRAIGE) is a is a multicentre, randomized, placebo-controlled, double-blind, prospective, investigator-led, clinical trial of tranexamic acid within 6 hours of intracerebral hemorrhage in patients with contrast extravasation on CTA, 'the spot sign'. ICH patients within 6 hours of symptom onset, with the spot sign as a biomarker for ongoing hemorrhage, and no contraindications for antifibrinolytic therapy were enrolled in TRAIGE. The patient with a spot sign will be randomized to receive either the active treatment or placebo, the patient with no spot sign will be given regular treatment as observation. The trial is anticipated to complete in 36 months from the first subject recruitment , with 240 subjects recruited. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by IRB(Institutional Review Board) /EC(Ethics Committee) in Beijing Tiantan hospital, Capital Medical University.

Conditions

Interventions

  • Tranexamic Acid (Cyklokapron)Drug
    ARM 1: Kind: Experimental
    Label: tranexamic acid
    Description: tranexamic acid
    ARM 2: Kind: Experimental
    Label: Placebo
    Description: 0.9% NaCl

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 hemorrhage growth 24±2 hours No
Secondary Major thromboembolic events 30±4 days Yes
Secondary Poor clinical outcome 90±7 days No
Secondary short-term outcome 30±4 days No
Secondary Other thromboembolic events 90±7 days No
Secondary Death due to any cause 90±7 days No

Sponsors