NCT00076648Unknown3 期
A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Group Study Using Provisions for Exception From Informed Consent Requirements Designed to Evaluate the Safety and Efficacy of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme(R)] When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting
Northfield Laboratories32 个研究点 分布在 1 个国家开始时间: 2004年1月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 32
研究概览
简要总结
This study is designed to assess the survival benefit of administering PolyHeme to severely injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where blood is not available, and continuing throughout a 12-hour postinjury hospital setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients following trauma who have sustained blood loss and are in shock
排除标准
- •Patients who have sustained unsurvivable injuries
- •Patients who have severe head injury
- •Pregnant females
- •Patients found in cardiac arrest
- •Patients who object to participation (e.g., religious grounds, wearing exclusion bracelet).
研究者
研究点 (32)
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