EUCTR2013-003368-29-AT进行中（未招募）1 期
EFFICACY OF VAS203 IN PATIENTS WITH MODERATE AND SEVERE TRAUMATIC BRAIN INJURY. A confirmatory, placebo-controlled, randomised, double blind, multi-centre study. - NOSTRA Phase III Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 232
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
- •Inclusion criteria
- •1.Written informed consent from patient’s legal guardian or legal representative or deferred consent procedure, according to local requirements
- •2.18 - 60 years of age, inclusive
- •3.Expected to survive more than 24 hours after admission
- •4.Traumatic Brain Injury (TBI) within the last 18 hours (infusion must not start earlier than 6 hours after the injury)
- •5.TBI with Glasgow Coma Score (GCS) = 3 requiring intracranial pressure (ICP) monitoring according to the assessment of the treating physician.
- •6.Catheter placement (intraventricular or intraparenchymal, only) for monitoring and management of increased ICP
- •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 232
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •1.Penetrating head injury (e.g. missile, stab wound)
- •2.Concurrent, but not pre-existing, spinal cord injury
- •3.Bilateral fixed and dilated pupil (> 4 mm). However, inclusion with unilateral fixed and dilated pupil (> 4 mm) is possible when there are no signs of herniation in transtentorial or temporal brain area.
- •4.Cardiopulmonary resuscitation performed post injury, or extracranial injuries causing continuing bleeding likely to require multiple transfusions (> 4 units red blood cells)
- •5.Coma due to an exclusive epidural hematoma (lucid interval and absence of structural brain damage on CT scan)
- •6.Coma suspected to be primarily due to other causes than head injury (e.g. drug overdose intoxication, drowning/near drowning)
- •7.Known or CT scan evidence of pre-existing major cerebral damage
- •8.Patients who cannot be monitored with regard to their recovery (eGOS-I and QOLIBRI)
- •9.Patients and relatives of patients who don´t understand/speak Spanish, or English, or French, or German (if Israel is included: Hebrew, Russian, Arabic).
- •10.Decompressive craniectomy, planned prior to randomisation
- •Note:enrolment is possible, when osteoplastic craniectomy is performed for hematoma evacuation, only
- •11.Polytraumatic patients with Injury Severity Score non-head > 18
- •12.Rhabdomyolysis with CK > 5000 IU/L
- •13.Injuries to ascending aorta and/or carotid arteries and vertebral arteries
- •14.Serum creatinine values > 1.2 mg/dL (106 µmol/L) (women), or > 1.5 mg/dL (133 µmol/L) (men)
- •15.Estimated glomerular filtration rate (eGFR) < 60 mL/min as calculated by Chronic Kidney Disease Epidemiology Collaboration Formula
- •16.BMI < 18.5 kg/m2 and > 40 kg/m2, Body weight > 110 kg
- •17.Any severe concomitant condition (cancer; hematologic, renal, hepatic,
- •coronary disease; major psychiatric disorder; alcohol or drug abuse), that
- •can be ascertained at admission
- •18.Known to have received an experimental drug within 4 weeks prior to
- •current injury
研究者
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