Trial intelligence / Profile preview

Hemospan vs Voluven for Hypotension in Hip Arthroplasty

NCT00420277Phase 3

Key facts

Status: Completed
Start: Feb 2007
Primary completion: Mar 2008
Countries: 5
Sponsor: Sangart
Modality: Recombinant Proteins and Enzymes, Small Molecules

Drugs: Hemospan
Conditions: hypotension

Overview

Phase 3, randomised, double-blind trial of Hemospan in hypotension (2 arms), sponsored by Sangart. Primary endpoint: Total duration of all hypotensive episodes. Started Feb 2007; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Hemospan
Hemospan (MP4OX) 250-500 mL
Voluven
Voluven (HES 130/0.4) 250-500 mL

Endpoints

Primary

Total duration of all hypotensive episodesUp to 6 hours after skin closure

Secondary

Incidence of serious operative and postoperative complications30 days
Incidence of operative and postoperative organ dysfunction related to ischemia and/or tissue hypoxia30 days
Mortality (In-hospital, and all-cause at 30 days)30 days
Time to resolve/correct the initial hypotensive episodeIntraoperative
Incidence of hypotensionUp to 6 hours after skin closure
Incidence of intervention with a pressor agentUp to 6 hours after skin closure

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