Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114647
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2005-06-15
Brief Title:
Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Procedures to Obtain Plasma Lymphocytes or Other Specimens for Research Studies
Status:
RECRUITING
Status Verified Date:
2024-10-01
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 collect blood plasma and white blood cells from individuals using a procedure called apheresis Apheresis is a method of collecting larger quantities of certain blood components that can safely be collected through a simple blood draw The blood components will be used in laboratory research studies
Patients 18 years of age and older who are currently enrolled in a NIH clinical research protocol may participate in this study Relatives of patients and normal healthy volunteers will also be enrolled
Individuals will undergo one of the following two apheresis procedures
Automated pheresis Blood is drawn through a needle placed in an arm vein and circulated through a cell separator machine The plasma liquid part of the blood and white cells are extracted and the red cells are re-infused into the donor through the same needle or a needle in the other arm An anticoagulant medication to prevent blood from clotting is usually added to the blood while in the machine to prevent it from clotting during processing
Manual pheresis One unit 1 pint of blood is drawn through a needle placed in an arm vein similar to donating a pint of whole blood The red blood cells with or without plasma are separated from the rest of the blood and returned to the donor through the same needle Manual pheresis will be done only when a person s estimated total blood volume or red cell count is too low to safely permit removal of blood through a pheresis machine An adult small in size or markedly anemic for example may fall into this category
Some of the blood collected through apheresis may be stored for future studies of HIV disease and immune function and for HLA testing a genetic test of markers of the immune system Some of the blood may be used to screen for different types of viral liver infections such as hepatitis A B C D E F or G
Patients 18 years of age and older who are currently enrolled in a NIH clinical research protocol may participate in this study Relatives of patients and normal healthy volunteers will also be enrolled
Individuals will undergo one of the following two apheresis procedures
Automated pheresis Blood is drawn through a needle placed in an arm vein and circulated through a cell separator machine The plasma liquid part of the blood and white cells are extracted and the red cells are re-infused into the donor through the same needle or a needle in the other arm An anticoagulant medication to prevent blood from clotting is usually added to the blood while in the machine to prevent it from clotting during processing
Manual pheresis One unit 1 pint of blood is drawn through a needle placed in an arm vein similar to donating a pint of whole blood The red blood cells with or without plasma are separated from the rest of the blood and returned to the donor through the same needle Manual pheresis will be done only when a person s estimated total blood volume or red cell count is too low to safely permit removal of blood through a pheresis machine An adult small in size or markedly anemic for example may fall into this category
Some of the blood collected through apheresis may be stored for future studies of HIV disease and immune function and for HLA testing a genetic test of markers of the immune system Some of the blood may be used to screen for different types of viral liver infections such as hepatitis A B C D E F or G
Detailed Description:
In order to carry out research procedures on the plasma or mononuclear components of blood it is often necessary to obtain larger quantities of plasma or mononuclear cells than can be safely obtained by simple phlebotomy These components can be easily and safely obtained using apheresis procedures in the Clinical Center Apheresis Unit Other specimens are also sometimes needed for research such as other blood components body fluids such as semen or urine or secretions from nose mouth or different skin areas While this protocol is specifically designed to conform to the requirements of the Apheresis Unit for donors to have apheresis and other collection procedures it also permits collection of these other donor specimens However the protocol by itself is not an independent research study but rather designed to facilitate sample collections that may aid other studies
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 |
|---|---|---|---|
| 81-I-0164 | None | None | None |