MedTrace Logo

Safety Study of Hemospan® in Prostatectomy Patients

NCT00425334 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-08-19

No results posted yet for this study

Summary

This is a progressive dose escalation study designed to evaluate the safety of Hemospan compared to a standard crystalloid solution (Ringer's lactate) in elective surgery patients undergoing total prostatectomy procedures with anticipated blood loss of more than 500 mL. Secondary objectives of this study are to observe possible activity of Hemospan for tissue oxygenation, perfusion and cardiovascular support.

Conditions

Interventions

DRUG

Hemospan (MP4OX)

250 mL or 500 mL Hemospan (MP4OX)

DRUG

Ringer's lactate

250 mL or 500 mL Ringer's lactate USP

Sponsors & Collaborators

  • Sangart

    lead INDUSTRY

Principal Investigators

  • John Ulatowski, M.D., Ph.D. · Johns Hopkins University

  • Peter E. Keipert, Ph.D. · Sangart, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2007-10-31
Completion
2007-11-30

Countries

  • United States

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 NCT00425334 on ClinicalTrials.gov