Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023023
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2001-08-18
Brief Title:
Study of Transfusion-Transmitted Infections
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Prospective Study of Transfusion-Transmitted Infections
Status:
COMPLETED
Status Verified Date:
2024-08-02
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 study will follow blood transfusion recipients for 6 to 9 months following transfusion to monitor the quality and safety of blood transfusion Improved viral testing and careful donor screening in the last several years has dramatically reduced the rates of transfusion-related HIV and hepatitis Nevertheless ongoing surveillance of transfusion-related infections is essential to maintain a high safety standard and to determine the transfusion risk of other infectious agents such as cytomegalovirus Epstein-Barr virus parvovirus B-19 HHV-8 Kaposi s sarcoma virus and other possible hepatitis viruses that might be blood-transmitted Transfused patients blood will be tested for various infectious agents Their blood samples and blood samples from their donors will be frozen and stored in a repository so that any new infectious agent can be rapidly evaluated for its danger to the safety of the blood supply
Adult patients at the National Institutes of Health and children at the Children s National Medical Center who are scheduled to receive a blood transfusion or to undergo surgery for which a blood transfusion may be needed are eligible for this study
All participants will have a 20- to 25-milliliter about 2 tablespoonfuls blood sample drawn before their transfusion and again at 1 2 4 12 and 24 weeks after the transfusion Patients who are transfused on more than one occasion over the course of the study will provide three additional monthly samples Patients who develop a transfusion-transmitted infection during the study will provide up to four more samples to study the infection and its effects Participants will complete a brief questionnaire at the end of the study regarding prior blood transfusions and the development of any illnesses such as hepatitis that might have been caused by the transfusion
Adult patients at the National Institutes of Health and children at the Children s National Medical Center who are scheduled to receive a blood transfusion or to undergo surgery for which a blood transfusion may be needed are eligible for this study
All participants will have a 20- to 25-milliliter about 2 tablespoonfuls blood sample drawn before their transfusion and again at 1 2 4 12 and 24 weeks after the transfusion Patients who are transfused on more than one occasion over the course of the study will provide three additional monthly samples Patients who develop a transfusion-transmitted infection during the study will provide up to four more samples to study the infection and its effects Participants will complete a brief questionnaire at the end of the study regarding prior blood transfusions and the development of any illnesses such as hepatitis that might have been caused by the transfusion
Detailed Description:
Improved viral screening assays and more intensive questioning of donors for high-risk behaviors have resulted in dramatic declines in the rates of transfusion-transmitted hepatitis and AIDS Nonetheless there is need for continued vigilance of the safety of blood supply This study will enroll blood donors and prospectively followed blood recipients in order to 1 establish ongoing surveillance of the incidence of breakthrough infections from transfusion-transmitted agents for which there are existing donor-screening assays eg HBV HCV HIV human T cell lymphotropic virus HTLV 2 monitor the transfusion risk of established infectious agents that are not routinely screened in blood donors including CMV parvovirus B-19 and HHV-8 Kaposis sarcoma virus 3 establish a repository of linked donor and recipient samples so that any newly emerging infectious agent can be rapidly evaluated for its threat to the blood supply
The risk of these blood transmitted infectious agents will be assessed by molecular and serologic assays in adult patients at NIH and Suburban Hospital in children at Childrens National Medical Center Blood samples from recipients transfused on one occasion will be obtained pre-transfusion and 1 2 4 12 and 24 weeks post-transfusion Recurrently transfused patients will have additional samples at 16 and 20 weeks after the index transfusion and 24 weeks after the last eligible transfusion After initial infectious disease testing recipient samples and linked donor samples will be stored in an off-site biorepository The availability of the repository will allow for the assessment of transfusion risk for newly emerging pathogens and also for known agents for which there is no practical assay currently available For example this would allow future testing for prions in new variant Creutzfeld-Jacob disease human variant of mad cow disease or testing for the trypanosome that causes Chagas disease Informed consent will be obtained to store and later test samples in the repository Testing will be limited to infectious agents that potentially threaten the blood supply No genetic testing will be performed
The risk of these blood transmitted infectious agents will be assessed by molecular and serologic assays in adult patients at NIH and Suburban Hospital in children at Childrens National Medical Center Blood samples from recipients transfused on one occasion will be obtained pre-transfusion and 1 2 4 12 and 24 weeks post-transfusion Recurrently transfused patients will have additional samples at 16 and 20 weeks after the index transfusion and 24 weeks after the last eligible transfusion After initial infectious disease testing recipient samples and linked donor samples will be stored in an off-site biorepository The availability of the repository will allow for the assessment of transfusion risk for newly emerging pathogens and also for known agents for which there is no practical assay currently available For example this would allow future testing for prions in new variant Creutzfeld-Jacob disease human variant of mad cow disease or testing for the trypanosome that causes Chagas disease Informed consent will be obtained to store and later test samples in the repository Testing will be limited to infectious agents that potentially threaten the blood supply No genetic testing will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 01-CC-0231 | None | None | None |