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

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00323752
First received: May 8, 2006
Last updated: September 24, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Scoliosis
Procedure: rHuEpo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recombinant Human Erythropoietin Compared to Autologous Pre-Donation Prior to Scoliosis Surgery in Children.

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Red cell mass at start of surgery [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Requirement for blood transfusion [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:

Background The pre-operative autologous donation (PAD) program was established at British Columbia's Children's Hospital in 1988 to decrease the need for homologous blood transfusion. It could alleviate the constraints arising from current and expected future shortages of homologous blood. But, primarily, the introduction of PAD was driven by concern about blood borne diseases.

A patient's own blood is generally considered to be the safest blood. However, the PAD program has several shortcomings. Firstly, venous access for blood withdrawal is often difficult in children. Secondly, the PAD program at British Columbia's Children's Hospital (BCCH) has a history of considerable wastage. Approximately 50% of pre-donated blood is discarded. Thirdly, a patient's medical condition or distance from BCCH can make participation in the program infeasible. Finally, even though the donor and recipient are the same, PAD is still susceptible to bacterial contamination and clerical errors. For example, it is possible that the wrong blood, either homologous blood or another patient's autologous blood, may be given to the PAD donor or another patient.

Wastage, cost, logistic challenges, and safety concerns have driven our interest in an alternative treatment for scoliosis patients. Recombinant human erythropoietin (rHuEpo) is a hormone that stimulates red cell production. This treatment has been used for patients scheduled for scoliosis surgery since 1990. However, it is not part of BCCH's current practice.

Study Objectives 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.

A pilot study of 20 subjects to investigate whether the gain in the PAD group is different from the group treated with rHuEpo..

Research Activities Females aged 12 to 18 years that are scheduled to undergo correction of idiopathic scoliosis by posterior fusion will be enrolled in the study. 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.

The primary measure of efficacy will be the gain in red cell mass in each group prior to surgery. The proportion of patients in each treatment group requiring transfusion as well as other pre-operative, peri-operative and post-operative risks will be compared. Thirty days after discharge, a survey will be administered to gauge individual patient and family acceptance of the treatments.

Expected Results Among patients scheduled for scoliosis surgery, rHuEpo treatment can significantly lower the rate of transfusion. RHuEpo treatment may lead to improved outcomes, such as decreased length of hospitalization. However, the true significance in this project lies in the investigation of rHuEpo treatment as an alternative to the PAD program that is safer and more accessible to patients and their families.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Scoliosis repair

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323752

Locations
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Eleanor Reimer, MD The University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Eleanor Reimer, University of British Columbia
ClinicalTrials.gov Identifier: NCT00323752     History of Changes
Other Study ID Numbers: C02-0510, W02-0166
Study First Received: May 8, 2006
Last Updated: September 24, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Blood loss, Erythropoetin

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014