Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist Oral Anticoagulants (NOAC) With Tranexamic Acid
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Hematoma expansion
研究概览
简要总结
Novel, non-vitamin K antagonist oral anticoagulants (NOAC) target selected players in the coagulation cascade as the direct thrombin inhibitor dabigatran and the factor Xa-inhibitors apixaban and rivaroxaban. Intracerebral hemorrhage (ICH) is the most feared complication of NOAC treatment (NOAC-ICH).
Outcome of NOAC-ICH can be devastating and is a major cause of death and disability. There is no proven treatment for NOAC-ICH. Hematoma expansion (HE) is associated with unfavorable outcome. Tranexamic acid (TA) is an anti-fibrinolytic drug that is used in a number of bleeding conditions other than ICH.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute intracerebral hemorrhage (symptom onset <12h)
- •Prior treatment with a novel direct oral anticoagulant (apixaban, dabigatran, edoxaban or rivaroxaban; last intake <48hours or proven NOAC activity by relevant coagulation assays)
- •Age >18 years, No upper age limit
- •Informed consent has been received in accordance to local ethics committee requirements
排除标准
- •Severe pre-morbid disability (modified Rankin scale >4)
- •Anticoagulation with Vitamin K antagonists (VKA) (recent intake)
- •Secondary intracerebral hemorrhage (e.g. arteriovenous malformation (AVM), tumor, trauma) Note it is not necessary for investigators to exclude underlying structural abnormality prior to enrolment, but where an underlying structural abnormality is already known, these patients should not be recruited.
- •Glasgow coma scale <5
- •pregnancy
- •Planned neurosurgical hematoma evacuation within 24 hours (before follow-up imaging)
- •Pulmonary embolism/deep vein thrombosis within the last 2 weeks.
研究组 & 干预措施
Tranexamic acid
Intravenous tranexamic acid: 1g loading dose given as 100 mls infusion over 10 minutes, followed by another 1g in 250 mls infused over 8 hours.
干预措施: Tranexamic acid (Drug)
Placebo
Saline 0.9% given in identical dosage as experimental
干预措施: Saline 0.9% (Drug)
结局指标
主要结局
Hematoma expansion
时间窗: up to 27 hours
Change in ICH-volume between baseline CT and follow-up-CT at 24 ± 3 hours of 33% relative or 6ml absolute increase
次要结局
- Absolute ICH growth volume by 24 ± 3 hours, adjusted for baseline ICH volume(up to 27 hours)
- modified Rankin Scale (mRS) 0-4 at month 3;(3 months)
- mRS 0-3 at month 3;(3 months)
- Categorical shift in mRS at month 3(3 months)
- mortality due to any cause at month 3(3 months)
- In-hospital mortality(baseline until discharge from hospital (stay at hospital lasts on an average of 10 days))
- Symptomatic HE defined as HE and additionally a neurological deterioration of NIHSS >4 points or Glasgow Coma Scale (GCS) >2 points(up to 27 hours)
- number of major thromboembolic events (myocardial infarction, ischemic stroke, pulmonary embolism - safety endpoints)(3 months)
- number of neurosurgical interventions (including craniectomy, external ventricular drain (EVD), hematoma evacuation)(3 months)