Status:
COMPLETED
Phase III Study of Hemospan® to Prevent Hypotension in Hip Arthroplasty
Lead Sponsor:
Sangart
Conditions:
Hypotension
Ischemia
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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...
Detailed Description
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, He...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00421200
Start Date
February 1 2007
End Date
June 1 2008
Last Update
August 19 2013
Active Locations (18)
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1
Univ. Ziekenhuis Antwerp
Antwerp, Belgium
2
Cliniques Universitaires Saint-Luc
Brussels, Belgium
3
ZOL Campus Sint-Jan
Genk, Belgium
4
AZ St. Lucas Hospital
Ghent, Belgium