NCT00421200

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

A Randomized, Double-blind, Phase III Study of the Efficacy and Safety of an Oxygen-carrying Plasma Expander, Hemospan®, Compared With Voluven® to Prevent Hypotension in Patients Undergoing Primary Hip Arthroplasty With Spinal Anesthesia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Sangart · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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, 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 functional hypovolemia due to loss of vascular tone that frequently causes acute hypotensive episodes. Hypotension represents a surrogate marker of hypovolemia that may be further exacerbated by surgical bleeding, which can result in decreased cardiac output, insufficient perfusion and inadequate tissue oxygenation. Ischemia resulting from hypotension can adversely affect vital organ function and may result in complications and postoperative morbidity. As the population ages and more patients become candidates for orthopedic reconstruction or joint replacement surgery, the number of patients at risk is increasing. The ideal IV solution for preventing hypovolemia-associated hypotension and improving hemodynamic stability would be an effective plasma expander that promotes tissue perfusion and delivers oxygen to ischemic or marginally hypoxic tissue. Preclinical animal studies have shown that Hemospan may be well-suited to this application and may even be better than blood in some situations. Data from Sangart's Phase II orthopedic surgery study (No. 6055), published recently by Olofsson et al. (Anesthesiology 2006; 105(6): 1153-63) support the safety and potential benefit of Hemospan for preventing hypotension in orthopedic surgery patients undergoing hip replacement surgery under spinal anesthesia.

Conditions

• Hypotension
• Ischemia

Interventions

Type	Name	Description
DRUG	Hemospan (MP4OX)	250 ml unit dose, up to 500 mL total dose, as needed at protocol-defined dosing triggers
DRUG	Voluven (HES 130/0.4)	250 ml unit dose, up to 500 mL total dose, as needed at protocol-defined dosing triggers

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-05-01
• Completion: 2008-06-01
• First posted: 2007-01-11
• Last updated: 2013-08-19

Locations

18 sites across 6 countries: Belgium, Czechia, Netherlands, Poland, Sweden, United Kingdom