EUCTR2009-012338-56-AT进行中（未招募）不适用
AN EXPLORATIVE PHASE IIa STUDY TO ASSESS SAFETY, TOLERABILITY,PHARMACODYNAMICS AND PHARMACOKINETICS OF VAS203 IN PATIENTS WITHMODERATE AND SEVERE TRAUMATIC BRAIN INJURY - NOSTRA TRIA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
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. Written informed consent from patient’s legal guardian or legal representative,
- •according to local requirements
- •2. 18 - 65 years of age, inclusive
- •3. Head trauma within the last 12 hours
- •4. TBI with Glasgow Coma Score (GCS) = 3 and that requires Intracranial pressure
- •(ICP) monitoring.
- •5. Catheter placement (intraventricular or intraparenchymal only) for monitoring and
- •management of increased ICP
- •6. Microdialysis probe placement in predominantly injured hemisphere ipsilateral to contusion if focal
- •(evaluated by computer tomography [CT])
- •7. Systolic blood pressure = 100 mmHg
- •8. Females of child-bearing potential must have a negative pregnancy test
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Penetrating head injury (e.g. missile, stab wound)
- •2. Not expected to survive more than 24 hours after admission
- •3. Concurrent, but not pre-existing, spinal cord injury
- •4. Unilateral and bilateral fixed and dilated pupil (> 4 mm)
- •5. Cardiopulmonary resuscitation performed post injury, or extracranial injuries causing continuing bleeding likely to require multiple transfusions (> 4 units red blood cells)
- •6. Coma due to a pure” epidural hematoma (lucid interval and absence of structural
- •brain damage on CT scan)
- •7. Coma suspected to be primarily due to other causes than head injury (e.g. drug
- •overdose, alcohol intoxication, drowning/near drowning)
- •8. Known or CT scan evidence of pre-existing major cerebral damage
- •9. Decompressive craniectomy, planned prior to randomisation/enrolment
- •10. Polytraumatic patients with Injury Severity Score non head > 18
- •11. Rhabdomyolysis with CK > 5000 IU/L
- •12. Injuries to ascending aorta and/or carotid arteries and/or vertebral arteries.
- •13. Serum creatinine values > 1.5 mg/dL (133 µmol/L)
- •14. Estimated glomerular filtration rate (eGFR) < 60 ml/min by Modification of Diet in
- •Renal Disease (MDRD) formula
- •15. Body mass index (BMI) < 19 kg/m2 and > 35 kg/m2, Body weight < 50 kg and > 120 kg.
- •16. Any severe concomitant condition (cancer; haematologic, renal, hepatic, coronary
- •disease; major psychiatric disorder; alcohol or drug abuse), that can be ascertained at admission
- •17. Known to have received an experimental drug within 4 weeks prior to current injury
- •18. Administration of > 100 ml of contrast media containing iodine
研究者
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