Increasing Dose Safety Study of Hemospan in Orthopedic Surgery Patients

NCT00494949 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-08-19

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and possible effectiveness of Hemospan solution in patients undergoing elective orthopedic surgery who receive spinal anesthesia.

Conditions

Interventions

DRUG

Hemospan (MP4OX)

200, 400, 600, 750, or 1000 mL of Hemospan (MP4OX)

DRUG

Ringer's lactate

200, 400, 600, 750, or 1000 mL of Ringer's lactate solution

Sponsors & Collaborators

  • Sangart

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2006-07-31
Completion
2006-08-31

Countries

  • Sweden

Study Locations

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Entities

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 NCT00494949 on ClinicalTrials.gov