Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 240
- 试验地点
- 11
- 主要终点
- hemorrhage growth
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
0.9% NaCl
干预措施: Tranexamic Acid (Drug)
tranexamic acid
tranexamic acid
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
hemorrhage growth
时间窗: 24±2 hours
either \>33% or \>6 ml increase from baseline, adjusted for baseline ICH volume
次要结局
- Major thromboembolic events(30±4 days)
- Other thromboembolic events(90±7 days)
- Death due to any cause(90±7 days)
- Poor clinical outcome(90±7 days)
- short-term outcome(30±4 days)
研究者
Liping Liu
Professor of Neurology and Stroke Center, Beijing Tiantan Hospital, Capital Medical University
Ministry of Science and Technology of the People´s Republic of China