EUCTR2009-013115-35-FR进行中（未招募）1 期
A multi-center, randomized, double-blind, controlled dose-finding study to evaluate the safety and efficacy of MP4OX treatment plus standard of care in severely injured trauma patients with lactic acidosis due to hemorrhagic shock
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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 study-related activities (study-related activities are any procedure that would not have been performed as standard of care for the patient).
- •2. Adult male or female (surgically sterile or post-menopausal or not pregnant), aged 18 to 80 years or of legal age to consent for participation in an investigational drug trial as per local law.
- •3. Trauma injury (blunt and/or penetrating) resulting in lactic acidosis due to hemorrhagic shock.
- •a. Lactic acidosis (lactate = 5 mmol/L; equivalent to = 45 mg/dL)
- •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. Not expected to survive 24 hours after randomization (based on physician judgment)
- •a. Massive injury incompatible with life
- •2. Patients with evidence of severe traumatic brain injury as defined by any one of the following:
- •a. Known non-survivable head injury or open brain injury; Glasgow Coma Score (GCS) = 3, 4 or 5, or known AIS = 5 if GSC > 5
- •b. Immediate open intracranial operation
- •c. Abnormal physical exam indicative of severe CNS or spinal injury
- •3. Patients with significant ongoing uncontrolled hemorrhage where control of bleeding is not expected within 2 hours of randomization.
- •4. Cardiac arrest prior to dosing.
- •5. Estimated time from injury to dosing > 4 hours.
- •6. Estimated time from hospital admission to randomization > 2 hours.
- •7. Known or suspected pregnancy (confirmed by urine test).
- •8. Previous participation in this study.
- •9. Professional or ancillary personnel involved with this study.
- •10. Receipt of any investigational drug(s) within 30 days prior to study.
研究者
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