EUCTR2020-004746-10-FI进行中（未招募）1 期
STOP-MSU – Stopping haemorrhage with Tranexamic acid for hyperacute Onset Presentation including Mobile Stroke Units - STOP-MS
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 326
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients presenting with an acute ICH
- •2. Age =18 years
- •3. Treatment can commence within 2 hours of symptom onset (or in patients with unknown time of symptom onset, the time patient was last known to be well)
- •4. Consent can be obtained from participant or person responsible. When emergency treatment procedures have been followed (where
- •permittable) the participant or person responsible will be asked for
- •consent to continue in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Glasgow coma scale (GCS) total score of <8
- •2. Brainstem ICH
- •3. ICH volume >70 ml as measured by the ABC/2 method
- •4. 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, tumour, or infection
- •5. 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.
- •6. Hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency.
- •7. Use of heparin, low-molecular weight heparin, GPIIb/IIIa antagonist, or oral anticoagulation (e.g. warfarin/vitamin K antagonists, factor Xa inhibitor, thrombin inhibitor) within the previous 72 hours. Warfarin/vitamin K antagonists must also have an INR of <1.3 prior to randomisation.
- •8. Pregnancy (women of childbearing potential must be tested)
- •9. Planned surgery for ICH within 24 hours
- •10. Concurrent or planned treatment with haemostatic agents (e.g. prothrombin complex concentrate, vitamin K, fresh frozen plasma, or platelet transfusion)
- •11. Participation in any investigational study in the last 30 days
- •12. Known terminal illness or planned withdrawal of care or comfort care measures.
- •13. 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.
研究者
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