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 prevention of perioperative hypotension in patients undergoing primary hip arthroplasty with spinal anaesthesia - 6084 Prevention Study
- Conditions
- Prevention of hypotensive episodes during anesthesia/surgery and through the postoperative period (defined as the first 6 hours following skin closure)MedDRA version: 8.1Level: LLTClassification code 10021097Term: Hypotension
- Registration Number
- EUCTR2006-002513-12-SE
- Lead Sponsor
- Sangart, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 370
• 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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether Hemospan is a superior colloid compared to Voluven for preventing hypotensive episodes during anesthesia/surgery and throughout the postoperative period (defined as the first 6 hours following skin closure);Secondary Objective: To determine whether Hemospan is a superior colloid compared to Voluven for reducing the incidence of operative and postoperative morbitidy (based on composite endpoints for organ dysfunction and failure) associated with ischemia and/or tissue hypoxia, until follow-up at 1 month following surgery (postoperative day 30 +/- 5);Primary end point(s): The proportion of patients who develop at least one hypotensive episode during anesthesia/surgery and throughout the postoperative period (the first 6 hours following skin closure)
- Secondary Outcome Measures
Name Time Method