Recombinant Human Erythropoietin Compared to Autologous Pre-Donation Prior to Scoliosis Surgery in Children.
2 other identifiers
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2004
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 8, 2006
CompletedFirst Posted
Study publicly available on registry
May 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedSeptember 25, 2008
September 1, 2008
3.2 years
May 8, 2006
September 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Red cell mass at start of surgery
21 days
Secondary Outcomes (1)
Requirement for blood transfusion
21 days
Interventions
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.
Eligibility Criteria
You may qualify if:
- Scoliosis repair
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eleanor Reimer, MD
The University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 8, 2006
First Posted
May 9, 2006
Study Start
October 1, 2004
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
September 25, 2008
Record last verified: 2008-09