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

NCT00421200 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2013-08-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Sangart

    lead INDUSTRY

Principal Investigators

  • Christina I. Olofsson, MD, PhD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-05-31
Completion
2008-06-30

Countries

  • Belgium
  • Czechia
  • Netherlands
  • Poland
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00421200 on ClinicalTrials.gov