Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004848
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-03-02
Brief Title:
A Controlled Prospective Study of Transfusion-Associated Hepatitis
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Controlled Prospective Study of Transfusion-Associated Hepatitis
Status:
COMPLETED
Status Verified Date:
1999-07
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:
This protocol represents a continuation of a series of prospective studies to define the incidence and etiology of transfusion-associated hepatitis TAH and to examine the impact on TAH of various modifications in the selection of blood donors
The primary goal of the study will be to determine TAH incidence after the institution of a variety of interventive measures to exclude hepatitis and AIDS virus carriers including surrogate assays ALT anti-HBc a specific assay for the hepatitis C virus HCV a specific assay for the human immunodeficiency virus HIV and intensified donor questioning for high-risk behavior patterns There is high probability that the exclusion of donors at high risk for AIDS transmission will also exclude donors at high risk for hepatitis transmission
Incidence data obtained in the study will be enhanced by the simultaneous follow-up of a control population undergoing identical surgical procedures but receiving no blood or only autologous blood This control population made possible by the recent dramatic increase in the amount of autologous blood utilized will allow for a clear distinction between transfusion-associated hepatitis and that due to nosocomial transmission or other background causes of hepatocellular inflammation in cardiac surgery patients
The primary goal of the study will be to determine TAH incidence after the institution of a variety of interventive measures to exclude hepatitis and AIDS virus carriers including surrogate assays ALT anti-HBc a specific assay for the hepatitis C virus HCV a specific assay for the human immunodeficiency virus HIV and intensified donor questioning for high-risk behavior patterns There is high probability that the exclusion of donors at high risk for AIDS transmission will also exclude donors at high risk for hepatitis transmission
Incidence data obtained in the study will be enhanced by the simultaneous follow-up of a control population undergoing identical surgical procedures but receiving no blood or only autologous blood This control population made possible by the recent dramatic increase in the amount of autologous blood utilized will allow for a clear distinction between transfusion-associated hepatitis and that due to nosocomial transmission or other background causes of hepatocellular inflammation in cardiac surgery patients
Detailed Description:
This protocol represents a continuation of a series of prospective studies to define the incidence and etiology of transfusion-associated hepatitis TAH and to examine the impact on TAH of various modifications in the selection of blood donors
The primary goal of the study will be to determine TAH incidence after the institution of a variety of interventive measures to exclude hepatitis and AIDS virus carriers including surrogate assays ALT anti-HBc a specific assay for the hepatitis C virus HCV a specific assay for the human immunodeficiency virus HIV and intensified donor questioning for high-risk behavior patterns There is high probability that the exclusion of donors at high risk for AIDS transmission will also exclude donors at high risk for hepatitis transmission
Incidence data obtained in the study will be enhanced by the simultaneous follow-up of a control population undergoing identical surgical procedures but receiving no blood or only autologous blood This control population made possible by the recent dramatic increase in the amount of autologous blood utilized will allow for a clear distinction between transfusion-associated hepatitis and that due to nosocomial transmission or other background causes of hepatocellular inflammation in cardiac surgery patients
The primary goal of the study will be to determine TAH incidence after the institution of a variety of interventive measures to exclude hepatitis and AIDS virus carriers including surrogate assays ALT anti-HBc a specific assay for the hepatitis C virus HCV a specific assay for the human immunodeficiency virus HIV and intensified donor questioning for high-risk behavior patterns There is high probability that the exclusion of donors at high risk for AIDS transmission will also exclude donors at high risk for hepatitis transmission
Incidence data obtained in the study will be enhanced by the simultaneous follow-up of a control population undergoing identical surgical procedures but receiving no blood or only autologous blood This control population made possible by the recent dramatic increase in the amount of autologous blood utilized will allow for a clear distinction between transfusion-associated hepatitis and that due to nosocomial transmission or other background causes of hepatocellular inflammation in cardiac surgery patients
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 |
|---|---|---|---|
| 81-CC-0110 | None | None | None |