EUCTR2004-004202-24-BE进行中（未招募）不适用
Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in Acute Intracerebral Haemorrhage
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 474
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. Spontaneous ICH (including bleeding in brainstem and cerebellum) diagnosed by CT scan within 3 hours of symptom onset
- •2. Male or female patients, aged =18 years (=20 in Taiwan)
- •3. Informed consent obtained before any trial related activities*. If permitted by local legislation informed consent can be provided by next of kin, a legally acceptable representative (LAR), physician statement or in countries where waiver of consent is allowed, a completed waiver form. Consent must also be obtained by the patient as soon as he/she is able to do so.
- •*Trial-related activities are any procedure that would not have been performed during normal management of the patient.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Time of symptom onset of ICH is unknown or more than 3 hours
- •2. Patients with secondary ICH related to infarction, tumour, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM), thrombolysis or severe trauma
- •3. Surgical haematoma evacuation planned within 24 hours of symptom onset
- •4. Deep coma (GCS 3-5) at the time of admission
- •5. Known oral anti-coagulant use (unless the INR is documented below 1.4); aspirin use is not an exclusion criterion
- •6. Known thrombocytopenia (unless current platelets documented above 50000/µL)
- •7. Pre-existing disability (i.e. must have a mRS score of 0-2 before stroke)
- •8. Any history of haemophilia or other coagulopathy
- •9. Known acute myocardial ischemia, acute septicaemia, acute crush injury, acute disseminated intravascular coagulation (DIC) or acute thrombotic stroke
- •10. Pregnancy
- •11. Known history of unstable angina or claudication within last 30 days, or any known history of myocardial infarction, ischaemic stroke, previous limb amputation due to vascular disease, deep vein thrombosis or pulmonary embolism
- •12. Known or suspected allergy to trial product or related products
- •13. Previous participation in this trial
- •14. Known participation in ANY investigational drug or device trial within 30 days of entry into this trial
- •15. Any other condition which, in the judgement of the Investigator, might increase the risk to the patient or preclude the satisfactory ability to collect experimental data
研究者
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