At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of an Oxygen-Carrying Plasma Expander, Hemospan®, Compared With Voluven® toTreat Hypotension in Patients Undergoing Primary Hip Arthroplasty With Spinal Anesthesia
In Brief
A Phase 3 clinical trial evaluating Hemospan (MP4OX) and Voluven (HES 130/0.4) for Hypotension and Ischemia. Completed, enrolled 462 participants across 22 sites in 5 countries.
Detailed Summary
The purpose of this study is to determine whether Hemospan is superior to Voluven for treatment of 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
Study Details
Timeline
Interventions
250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers
250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers