Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign

Ministry of Science and Technology of the People´s Republic of China240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

240

Conditions

Intracerebral Hemorrhage Stroke

Interventions

Tranexamic AcidDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients presenting with an acute spontaneous hypertensive Intracerebral hemorrhage 1. CTA evaluation can be accomplished within 6 hours of symptom onset, with "spot sign" positive in CTA original image 2. Age range from 18 to 79 years 3. Randomization can be finished and treatment can commence within 8 hours of symptom onset 4. Informed consent has been received in accordance to local ethics committee requirements Exclusion Criteria: 1. ICH known or suspected to be secondary to tumour, vascular malformation, aneurysm or trauma 2. Infratentorial ICH 3. Glasgow coma scale (GCS) total score of \<8 4. ICH volume \>70 ml 5. Parenchymal hemorrhage with ventricle involved, blood completely fills one lateral ventricle or more than half of both lateral ventricles 6. Contraindication of CTA imaging (e.g. known or suspected iodine allergy or significant renal failure) 7. 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. 8. Planned surgery for ICH 9. Pregnancy or within 30 days after delivery, or during lactation 10. Use of heparin, low-molecular weight heparin, or oral anticoagulation within the previous 1 week, with abnormal laboratory values 11. Known allergy to tranexamic acid 12. Prestroke modified mRS score of \>2

Locations (11)

Aviation General Hospital

Beijing, Beijing Municipality, China

NOT_YET_RECRUITING

Beijing Fangshan District Liangxiang Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

hemorrhage growth

either \>33% or \>6 ml increase from baseline, adjusted for baseline ICH volume

Time frame: 24±2 hours

Secondary Outcomes

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

Central Contacts

Liping Liu, MD

CONTACT

8610-67098368 lipingsister@gmail.com

Data from ClinicalTrials.gov

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