Phase III Study of Hemospan® for Treating Hypotension in Hip Arthroplasty

Launched by SANGART · Jan 9, 2007

Keywords

ClinConnect Summary

Hemospan is a novel hemoglobin-based oxygen carrier developed to perfuse and oxygenate tissue at risk for ischemia and hypoxia. As a result of its molecular size and oxygen binding characteristics, Hemospan selectively off-loads oxygen in tissues predisposed to low oxygen tension. Preclinical evidence suggests that Hemospan provides rapid and effective plasma expansion and tissue perfusion, and that the properties of Hemospan target oxygen release in the microcirculation.

Spinal anesthesia is the preferred choice for hip arthroplasty procedures in elderly patients, but is associated with a...

Gender

ALL

Eligibility 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