Phase III Study of Hemospan® to Prevent Hypotension in Hip Arthroplasty

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Hemospan is superior to Voluven for preventing hypotensive episodes during the perioperative period (from induction of spinal anesthesia until 6 hours after skin closure), and for reducing the incidence of operative and postoperative complications including organ dysfunction and failure until follow-up at one month following surgery. An independent Data Safety Monitoring Board (DSMB) will periodically evaluate the safety data collected during this trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sangart
• Treatments: Hydroxyethyl Starch Derivatives; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Patients scheduled to undergo elective primary hip arthroplasty (based on an osteoarthritis diagnosis) under spinal anesthesia

• Adult male or female (surgically sterile or post-menopausal), aged 50 years or older

• American Society of Anesthesiology (ASA) Class II or III

• Physical examination, laboratory status, vital signs, and ECG within acceptable limits for the planned surgery, as judged by the investigator

• Have been given written and verbal information by the investigator about Hemospan and the protocol, and have had the opportunity to ask questions about the study

• Patients must sign an Informed Consent form that has been reviewed and approved by the independent Ethics Committee

Exclusion Criteria:

• 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 SBP >180 mmHg, or a difference in SBP obtained in each arm that is >15 mmHg (measured in the supine position in both arms, at screening)

• 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