EUCTR2006-002514-35-SE进行中（未招募）不适用
A multi-center, randomized, double-blind, controlled Phase III study of the efficacy and safety of an oxygen-carrying colloid and plasma expander, Hemospan, compared with colloid (Voluven) for treatment of perioperative hypotension in patients undergoing primary hip arthroplasty with spinal anesthesia - 6090 Treatment Study
适应症
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
- 460
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
- •Patients scheduled to undergo elective primary hip arthroplasty (based on osteoarthritis diagnosis) with spinal anesthesia
- •Adult male or female (surgically sterile or post-menopausal) subjects, aged >/= 50 years
- •American Society of Anesthesiology (ASA) Class II or III
- •Physical examination, laboratory status, vital signs, and an electrocardiogram (ECG) within acceptable limits for surgery, as judged by the investigator
- •Has been given written and verbal information about the study drug and the protocol by a study investigator and has had the opportunity to ask questions about the study
- •Patients must sign an Informed Consent form (ICF), that has been reviewed and approved by the independent Ethics Committee (EC)
- •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
- •Hip fracture patients and nail/pin extraction procedures
- •Clinical evidence of uncontrolled cardiovascular, infectious, psychiatric, metabolic or systemic disorders including diabetes and rheumatoid arthritis
- •Evidence of significant hypertension with systolic blood pressure (BP) >180 mmHg, or a difference in systolic BP obtained in each arm that is >/=15 mmHg (measured at screening in the supine position, in both arms)
- •Recent history or evidence of MI or stroke (within 6 months)
- •Known alcohol or drug dependency
- •Currently taking oral anti-coagulant therapy; except for low-dose aspirin (acetylsalicylic acid), < 200 mg/day
- •History of coagulopathy
- •Involved in any investigational drug or device trial within 30 days prior to this study
- •Professional or ancillary personnel involved with this study
研究者
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