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临床试验/NCT00323752
NCT00323752已完成3 期

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

University of British Columbia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2004年10月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Red cell mass at start of surgery

研究概览

简要总结

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.

详细描述

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..

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Scoliosis repair

排除标准

  • 未提供

结局指标

主要结局

Red cell mass at start of surgery

时间窗: 21 days

次要结局

  • Requirement for blood transfusion(21 days)

研究者

申办方类型
Other

研究点 (1)

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