Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005341
Status:
TERMINATED
Last Update Posted:
2024-03-12
First Post:
2000-05-25
Brief Title:
Blood Donation--Immune Sequelae and Recruitment
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not a clinical trial and was inadvertently entered in the system
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine if there were immune sequelae related to the long-term donation of blood or blood products
Detailed Description:
DESIGN NARRATIVE
The study had two objectives The first objective was to investigate changes in immune function which may have occurred as a result of blood plasma or platelet donations Preliminary studies had shown evidence of alterations in immune parameters in normal apheresis donors with the most marked changes occurring in long-term plasmapheresis donors To ascertain whether donation of blood or blood products altered specific immune parameters studies were conducted on white blood cell WBC receptors known to be involved in normal host defense mechanisms lymphocyte subpopulations plasma proteins and complement activation products from 30 individuals in each of four separate donor groups whole blood donors bulk plasma donors plasma donors stimulated with incompatible RBC and platelet donors Donor immune data were compared with results in nondonor controls and were also correlated with demographic data donation history laboratory data and clinical findings The second objective of the study was to determine if changes in an individual donors immune status occurred over time A longitudinal study of 15 new donors in each donation group was performed to evaluate alterations in immune function that may have occurred in committed donors of blood products and whether there was any clinical significance to the findings New donors were enrolled in donation groups and followed longitudinally for a period of up to two years
The study was extended through January 1997 on FY 1995 funds
The study had two objectives The first objective was to investigate changes in immune function which may have occurred as a result of blood plasma or platelet donations Preliminary studies had shown evidence of alterations in immune parameters in normal apheresis donors with the most marked changes occurring in long-term plasmapheresis donors To ascertain whether donation of blood or blood products altered specific immune parameters studies were conducted on white blood cell WBC receptors known to be involved in normal host defense mechanisms lymphocyte subpopulations plasma proteins and complement activation products from 30 individuals in each of four separate donor groups whole blood donors bulk plasma donors plasma donors stimulated with incompatible RBC and platelet donors Donor immune data were compared with results in nondonor controls and were also correlated with demographic data donation history laboratory data and clinical findings The second objective of the study was to determine if changes in an individual donors immune status occurred over time A longitudinal study of 15 new donors in each donation group was performed to evaluate alterations in immune function that may have occurred in committed donors of blood products and whether there was any clinical significance to the findings New donors were enrolled in donation groups and followed longitudinally for a period of up to two years
The study was extended through January 1997 on FY 1995 funds
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL045642 | NIH | None | httpsreporternihgovquickSearchR01HL045642 |