Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS, Hematology |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 1/17/2019 |
| Start Date: | October 19, 1981 |
| Contact: | Holly A Baus, R.N. |
| Email: | holly.baus@nih.gov |
| Phone: | (301) 761-6800 |
Procedures to Obtain Plasma, Lymphocytes, or Other Specimens for Research Studies
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.
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.
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.
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.
- INCLUSION CRITERIA:
18 years of age or older
Adequate venous access
Blood pressure less than or equal to 180/100; pulse rate 50-100, unless a lower pulse rate
is considered normal for the volunteer (e.g. a conditioned athlete)
Adequate blood counts if undergoing apheresis (HIV positive volunteers and volunteers with
vasculitis or other inflammatory diseases: hemoglobin greater than or equal to 9.0 g/dL,
HCT greater than or equal to 28%, platelets greater than or equal to 50,000; HIV negative
volunteers: hemoglobin greater than or equal to 12.5 g/dL, HCT greater than or equal to
38%, platelets greater than or equal to 150,000)
Willing and able to provide written informed consent, comply with study requirements and
procedures, and comply with clinic policies (including stored samples, hepatitis screening,
and genetic testing including HLA testing)
EXCLUSION CRITERIA:
Pregnant and/or breast-feeding if undergoing apheresis; however, for other sample
collection procedures such as simply phlebotomy or fluid collections these are not
considered exclusion criteria
Currently abusing alcohol or other drugs
Any medical condition for which the PI feels apheresis or other sample collection
proceduresmight be contraindicated
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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