NCT01702636已完成2 期
STOP-AUST: The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume.
研究概览
简要总结
The aim of the study is to test if intracerebral haemorrhage (ICH) patients who have contrast extravasation on computed tomography angiography, the "spot sign", have lower rates of haematoma growth when treated with tranexamic acid within 4.5 hours of stroke onset, compared to placebo.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with an acute ICH
- •Contrast extravasation within the haemorrhage, "spot sign", evaluated from the CTA according to three criteria, all of which must be present:
- •Serpiginous or spot-like appearance within the margin of a parenchymal haematoma without connection to an outside vessel;
- •The density (in Hounsfield units) should be greater than that of the background haematoma (site investigators are not required to document the density); and
- •No hyperdensity at the corresponding location on non-contrast CT.
- •Age ≥18 years
- •Treatment can commence within 1 hour of initial CT and within 4.5 hours of symptom onset (or in patients with unknown time of symptom onset, the time patient was last known to be well)
- •Informed consent has been received in accordance to local ethics committee requirements
排除标准
- •Glasgow coma scale (GCS) total score of <8
- •Brainstem ICH
- •ICH volume >70 ml as measured by the ABC/2 method
- •ICH known or suspected by study investigator to be secondary to trauma, aneurysm, vascular malformation, haemorrhagic transformation of ischaemic stroke, cerebral venous thrombosis, thrombolytic therapy, tumor, or infection
- •Contrast already administered within 24 hours prior to initial CT or contraindication to imaging with CT contrast agents (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 12 months, including clinical, ECG, laboratory, or imaging findings. Clinically silent chance findings of old ischemia are not considered exclusion.
- •Hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency.
- •Use of heparin, low-molecular weight heparin, GPIIb/IIIa antagonist, or oral anticoagulation (e.g. warfarin, factor Xa inhibitor, thrombin inhibitor) within the previous 14 days, irrespective of laboratory values
- •Pregnancy (women of childbearing potential must be tested)
- •Planned surgery for ICH within 24 hours
- •Concurrent or planned treatment with haemostatic agents (e.g. prothrombin complex concentrate, vitamin K, fresh frozen plasma, or platelet transfusion)
- •Participation in any investigational study in the last 30 days
- •Known terminal illness or planned withdrawal of care or comfort care measures.
- •Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
研究组 & 干预措施
Tranexamic Acid
Active Comparator
Intravenous tranexamic acid 1000 mg in 100 mL 0.9% NaCl over 10 minutes followed by 1000 mg in 500 mL 0.9% NaCl infusion over 8 hours.
干预措施: Tranexamic Acid (Drug)
Placebo
Placebo Comparator
Intravenous placebo in 100 mL 0.9% NaCl over 10 minutes followed by 500 mL 0.9% NaCl infusion over 8 hours.
干预措施: Placebo (Drug)
结局指标
主要结局
ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume.
时间窗: 24+/-3 hours
次要结局
- Absolute ICH growth volume by 24±3 hours, adjusted for baseline ICH volume(24+/-3 hours)
- Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism)(Within 90+/-7 days)
- Absolute intraventricular haematoma (IVH) growth volume by 24±3 hours, adjusted for baseline IVH volume(24+/-3 hours)
- modified Rankin Scale (mRS) score of 0-4 at 3 months(90+/-7 days)
- Categorical shift in mRS at 3 months, subject to the validity of proportional odds assumption(90+/-7 days)
- modified Rankin Scale (mRS) score of 0-3 at 3 months(90+/-7 days)
- Death due to any cause by 3 months(within 90+/-7 days)
研究者
研究点 (11)
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