Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001349
Status:
TERMINATED
Last Update Posted:
2021-11-10
First Post:
1999-11-03
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:
Apheresis Procedures to Obtain Plasma or Leukocytes for In Vitro Studies
Status:
TERMINATED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed at the request of the IRBO
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 for laboratory research using a procedure called apheresis Apheresis is a method of collecting larger quantities of certain blood components than can safely be collected through a simple blood draw
Patients 7 years of age and older with a parasitic infection or condition associated with a parasitic infection ie elevated levels of IgE antibodies or of a type of white cell called eosinophils who are currently enrolled in a NIH clinical research protocol may be eligible for this study Relatives of patients and normal healthy volunteers will also be enrolled Candidates will have a medical history physical examination and blood tests Individuals weighing less than 25 kilograms 55 pounds may not participate
Participants will undergo one of the following two apheresis procedures
Automated pheresis Whole 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 a needle in the other arm The procedure takes 1 to 2 hours
Manual pheresis Whole blood is drawn through a needle placed in an arm vein and circulated through the cell separator machine The red blood cells are separated from the rest of the blood and returned to the donor through the same needle Usually only one needle stick is required and the procedure takes from 30 to 45 minutes This method is used only in individuals who weigh less than 35 kg 77 pounds
Patients 7 years of age and older with a parasitic infection or condition associated with a parasitic infection ie elevated levels of IgE antibodies or of a type of white cell called eosinophils who are currently enrolled in a NIH clinical research protocol may be eligible for this study Relatives of patients and normal healthy volunteers will also be enrolled Candidates will have a medical history physical examination and blood tests Individuals weighing less than 25 kilograms 55 pounds may not participate
Participants will undergo one of the following two apheresis procedures
Automated pheresis Whole 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 a needle in the other arm The procedure takes 1 to 2 hours
Manual pheresis Whole blood is drawn through a needle placed in an arm vein and circulated through the cell separator machine The red blood cells are separated from the rest of the blood and returned to the donor through the same needle Usually only one needle stick is required and the procedure takes from 30 to 45 minutes This method is used only in individuals who weigh less than 35 kg 77 pounds
Detailed Description:
In order to carry out in vitro research procedures on the plasma or leukocyte components of blood it is often necessary to obtain larger quantities of plasma andor leukocytes 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 This protocol is specifically designed to conform to the requirements of the Apheresis Unit for donors to have apheresis procedures 7 years of age and greater than or equal to 25kg Donors must first be admitted to another approved clinical research protocol of the LPD NIAID before they may have the apheresis procedures described in this protocol The investigational nature of the studies in which the samples will be used as well as the risks and benefits of the donation process will be explained to all donors and a signed informed consent document will be obtained
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 |
|---|---|---|---|
| 93-I-0057 | None | None | None |