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Recombinant Human Erythropoietin Compared to Autologous Pre-Donation Prior to Scoliosis Surgery in Children.

NCT00323752 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-09-25

No results posted yet for this study

Summary

The purpose of this study is to establish whether rHuEpo is as effective as PAD in increasing red cell mass prior to surgery. Other benefits of the PAD program and preoperative administration of rHuEpo will also be compared.

Conditions

  • Scoliosis

Interventions

PROCEDURE

rHuEpo

Subjects will be randomly assigned to either participate in the PAD program or receive the rHuEpo treatment. Subjects in the PAD group will donate 1 unit of blood at -14 and -7 days prior to surgery. A dose of 500 IU of rHuEpo will be administered subcutaneously to subjects in the rHuEpo group at -21, -14, and -7 days prior to surgery.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Eleanor Reimer, MD · The University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Canada

Study Locations

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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 NCT00323752 on ClinicalTrials.gov