Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign

Study Overview
=================
Brief 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
-----------------
Intracerebral Hemorrhage, Stroke

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with an acute spontaneous hypertensive Intracerebral hemorrhage CTA evaluation can be accomplished within 6 hours of symptom onset, with spot sign positive in CTA original image Age range from 18 to 79 years Randomization can be finished and treatment can commence within 8 hours of symptom onset Informed consent has been received in accordance to local ethics committee requirements Exclusion Criteria: ICH known or suspected to be secondary to tumour, vascular malformation, aneurysm or trauma Infratentorial ICH Glasgow coma scale (GCS) total score of <8 ICH volume >70 ml Parenchymal hemorrhage with ventricle involved, blood completely fills one lateral ventricle or more than half of both lateral ventricles Contraindication of CTA imaging (e.g. known or suspected iodine allergy or significant renal failure) Any history or current evidence suggestive of venous or arterial thrombotic events within the previous 6 months, including clinical, ECG, laboratory, or imaging findings. Clinically silent chance findings of old ischemia are not considered exclusion. Planned surgery for ICH Pregnancy or within 30 days after delivery, or during lactation Use of heparin, low-molecular weight heparin, or oral anticoagulation within the previous 1 week, with abnormal laboratory values Known allergy to tranexamic acid Prestroke modified mRS score of >2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tranexamic acid<br>tranexamic acid | Drug: Tranexamic Acid<br> <br> |
| Placebo Comparator: Placebo<br>0.9% NaCl | Drug: Tranexamic Acid<br> <br> |
| No Intervention: observation(spot sign -)<br>regular clinical treatment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemorrhage growth | either >33% or >6 ml increase from baseline, adjusted for baseline ICH volume | 24±2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major thromboembolic events | (1) acute myocardial ischemia; (2) acute cerebral ischemia; and (3) acute pulmonary embolism | 30±4 days | 
| Poor clinical outcome | The Number of patients that is Death or major disability(mRS 4-6) | 90±7 days | 
| short-term outcome | The Number of patients that with Modified Rankin Scale (mRS) 0-2 at 30±4 days | 30±4 days | 
| Other thromboembolic events | Other thromboembolic events，such as venous thrombosis and other peripheral arterial embolism | 90±7 days | 
| Death due to any cause | Number of patients that is Death due to any cause by 90±7 days | 90±7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intracerebral Hemorrhage, tranexamic acid, spot sign