Trials / Unknown
UnknownNCT02625948
Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- Sponsor
- Ministry of Science and Technology of the People´s Republic of China · Other Government
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Not accepted
Summary
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
| Type | Name | Description |
|---|---|---|
| DRUG | Tranexamic Acid |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2018-12-01
- First posted
- 2015-12-09
- Last updated
- 2016-09-14
Locations
11 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02625948. Inclusion in this directory is not an endorsement.