CLINICAL TRIALS
Hemospan® has been tested in over 90 patients to date including a multi-site Phase II clinical trial completed in Sweden in 2005. No serious adverse events attributable to Hemospan® have been noted in any of these trials.
Phase I - Sweden
Status: Complete
A Single-Blind, Placebo-Controlled, Rising Dose Safety and Tolerance Study of Hemospan at Doses of 50MG HB/KG, and 250MG HB/KG Given as an Intravenous Infusion in Three Separate Cohorts Using a Total of Eighteen Normal Healthy Volunteers
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Phase Ib/II - Sweden
Status: Complete
Clinical Safety (Phase Ib/II) Increasing Dose Study of MP4 (Hemospan®) in Orthopedic Surgery Patients.
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Phase II- Sweden
Status: Complete
A Multi-Center, Double Blind, Placebo Controlled, 3 Way Randomized Clinical Study of the Safety and Efficacy of 250 and 500 ML of MP4 (Hemospan®) When Used During Spinal Anesthesia in Patients Undergoing Major Orthopedic Surgery
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Phase II - USA
Status: Ongoing
A Clinical Safety (Phase II) Increasing Dose Study of MP4 (Hemospan®) in Total Prostatectomy Surgical Patients.
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Phase III - Europe
Status: Ongoing
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 anesthesia.
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Phase III - Europe
Status: Ongoing
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.
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