Recombinant Human Erythropoietin Compared to Autologous Pre-Donation Prior to Scoliosis Surgery in Children.
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): rHuEpo
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood loss, Erythropoetin