A Phase 2 interventional study of Tranexamic Acid in Intracerebral Hemorrhage and Stroke, sponsored by Ministry of Science and Technology of the People´s Republic of China. Status unknown at 11 sites in China. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2016-09-14.
Sponsored by Ministry of Science and Technology of the People´s Republic of China · Phase 2, Interventional, and Treatment
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
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.
476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.
This study's planned enrollment of 240 is above the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Ministry of Science and Technology of the People´s Republic of China is the lead sponsor of 21 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting with an acute spontaneous hypertensive Intracerebral hemorrhage
Exclusion Criteria:
tranexamic acid
Drug: Tranexamic Acid
0.9% NaCl
Drug: Tranexamic Acid
regular clinical treatment
hemorrhage growth
either \>33% or \>6 ml increase from baseline, adjusted for baseline ICH volume
Time frame: 24±2 hours
Major thromboembolic events
(1) acute myocardial ischemia; (2) acute cerebral ischemia; and (3) acute pulmonary embolism
Time frame: 30±4 days
Poor clinical outcome
The Number of patients that is Death or major disability(mRS 4-6)
Time frame: 90±7 days
short-term outcome
The Number of patients that with Modified Rankin Scale (mRS) 0-2 at 30±4 days
Time frame: 30±4 days
Other thromboembolic events
Other thromboembolic events，such as venous thrombosis and other peripheral arterial embolism
Time frame: 90±7 days
Death due to any cause
Number of patients that is Death due to any cause by 90±7 days
Time frame: 90±7 days
Absolute ICH growth volume
The absolute ICH growth volume compared with the baseline CT scan
Time frame: 24±2 hours
Absolute IVH growth volume
The absolute IVH growth volume compared with the baseline CT scan
Time frame: 24±2 hours
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Ministry of Science and Technology of the People´s Republic of China