Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323752
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2006-05-08
Brief Title:
Recombinant Human Erythropoietin Compared to Autologous Pre-Donation Prior to Scoliosis Surgery in Children
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Recombinant Human Erythropoietin Compared to Autologous Pre-Donation Prior to Scoliosis Surgery in Children
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Background The pre-operative autologous donation PAD program was established at British Columbias Childrens 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 patients 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 Columbias Childrens Hospital BCCH has a history of considerable wastage Approximately 50 of pre-donated blood is discarded Thirdly a patients 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 patients 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 BCCHs 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
A patients 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 Columbias Childrens Hospital BCCH has a history of considerable wastage Approximately 50 of pre-donated blood is discarded Thirdly a patients 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 patients 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 BCCHs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| W02-0166 | None | None | None |