EUCTR2004-000088-92-FI进行中（未招募）不适用
A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa (NovoSeven®/Niastase®) with Brain Contusions.
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
- 96
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. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). Signed informed consent may be obtained either from the subject and/or his/her legally acceptable representative (LAR).
- •2. Contusive brain injury (including brain stem) diagnosed by history, clinical examination and confirmed by CT scan within 6 hours of onset.
- •3. Head CT scan showing intraparencymal haemorrhage (one or more contusions) with a total minimum volume of greater than or equal to 2ml and at least one single intraparenchymal haemorrhage greater than or equal to 1ml as detected determined by the ABC/2 method.
- •4. Male or female subjects, age 18 years or over.
- •5.GCS between 4 and 14 (both inclusive) or if GCS cannot be assessed: a motor score of 2-5 (both inclusive).
- •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. Life expectancy less than 24 hours after injury
- •2. Any planned surgery of parenchymal lesions in the brain within 24 hours of dosing
- •3. Time of CBI unknown or > 6 hours prior to initial CT scan
- •4. Penetrating brain injury (e.g. gunshot wounds, stab wounds)
- •5. Body weight greater than or equal to 160 kg
- •6. Spinal cord injury
- •7. The following CT findings in isolation: pure subarachnoid haemorrhage, pure intra-ventricular haemorrhage, pure epidural haemorrhage pure subdural haemorrhage or suspicion of a spontaneous intracerebral haemorrhage
- •8. Subjects with significant cardiovascular dysfunction or haemodynamic instability due to haemorrhage, e.g. systolic blood pressure ? 90 mmHg and/or red blood cell transfusion needed to maintain haemodynamic stability before the initial CT scan
- •9. Subjects scheduled to surgery or any other procedure that according to the judgement of the investigator will interfere with the planned study procedures
- •10. Subjects with known previous major cerebral diseases (traumatic or non-traumatic) with permanent neurological deficits (i.e. subjects with a pre-injury modified Rankin Score of 3 or higher)
- •11. Known history of hypercoagulable state and/or thromboembolism (e.g. ischemic stroke, DVT, PE or AMI)
- •12. Known thrombocytopenia (thrombocytes < 50 x 10 x9/l)
- •13. Known current use of vitamin K-antagonists unless INR < 1.4
- •14. Pregnancy
- •15. Known or suspected allergy to trial product or related products
- •16. Previous participation (randomised) in this trial
- •17. Known receipt of any investigational drug within 30 days prior to this trial
- •18. Any other condition which, in the judgement of the investigator, might increase the risk to the subject or preclude the satisfactory ability to collect experimental data
研究者
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