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View Clinical Trial (Medical Research Study)
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Blood Component Collection From Patients With Rheumatic Disease and Healthy Volunteers - NCT00031174-20892 (Clinical Trial 114145)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy114145.aspx
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| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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Rheumatic Diseases - Healthy |
| Purpose: |
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This study will collect white blood cells or plasma (the liquid part of the blood), or both,
from healthy volunteers and from patients with rheumatic disorders for research purposes.
Rheumatic disorders involve abnormalities of the immune system, the body's defense against
disease. The immune system consists of white blood cells such as lymphocytes and monocytes,
which produce substances such as antibodies and cytokines. White cells and plasma will be
collected through a procedure called apheresis (described below).
Healthy volunteers and patients with confirmed or suspected rheumatic disease who are 18
years of age or older may be eligible for this study. Patients must be participating in a
current protocol of the National Institute of Arthritis and Musculoskeletal and Skin
Diseases. All candidates will be screened with a history, physical examination, and blood
tests for hepatitis B and C and HIV infection. Women of childbearing age will be tested for
pregnancy. Routine blood tests will be done in all volunteers, and in patients where needed.
Pregnant women and people who test positive for hepatitis or HIV may not participate.
Participants will undergo apheresis to collect lymphocytes, monocytes, or plasma from the
blood. For this procedure, a needle is placed in a vein in the arm. Blood flows from the
vein through a tube (catheter) into a machine that spins the blood, separating it into its
components. The required cells or plasma are extracted, and the rest of the blood, including
the red cells and platelets, is returned to the body through the same needle or through a
second needle placed in the other arm.
Cells collected from volunteers will be used in studies comparing the number and function of
similar cells from patients with rheumatic diseases, focusing on the differences in number
and function of the cells in health and disease. Components collected from patients will be
used only for studies described in the protocol in which they are currently enrolled.
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| Study summary: |
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Blood components will be collected using apheresis from normal volunteers and patients with
rheumatic diseases. Mononuclear cells and plasma will be used by various investigators for
research studies. |
| Criteria: |
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- INCLUSION CRITERIA - Subjects with Rheumatic Diseases:
Patients with a diagnosed or suspected rheumatic disease, who are actively involved in a
NIAMS protocol (have a current, signed consent form)
Ability to give informed consent
Age greater than or equal to 18 years
EXCLUSION CRITERIA - Subjects with Rheumatic Diseases:
History of allergy to acid-citrate-dextrose (ACD) anticoagulant
History of bleeding diatheses
Hemoglobin less than 9.0 g/dL
Platelet count less than 50,000/mm(3)
Pregnancy
Inadequate peripheral venous access
Active hepatitis B, C and/or HIV infection
Symptomatic coronary artery or valvular heart disease
Any concomitant illness that in the opinion of the investigators will substantially
increase risk of apheresis.
INCLUSION CRITERIA - Healthy Volunteers:
Subjects shall meet all donor eligibility criteria for autologous blood donation
recommended or required by the Standards of the American Association of Blood Banks (1)
and the Code of Federal Regulations of the Food and Drug Administration (2), with the
exception of the travel exclusions related to malaria exposure and hypothetical exposure
to the agent of variant Creutzfeldt-Jacob disease.
Ability to give informed consent
Age greater than or equal to 18 years
EXCLUSION CRITERIA - Healthy Volunteers:
History of autoimmune or chronic rheumatic disease within the last 5 years, with the
exception of osteoarthritis
Active hepatitis B, C, and/or HIV infection
History of allergy to acid-citrate (ACD) anticoagulant
History of coagulopathies and bleeding diatheses
Symptomatic coronary artery disease or valvular heart disease
Hemoglobin less than 12.0 g/dL
Platelet count less than 100,000/cubic mm
Pregnancy
Inadequate peripheral venous access
Any concomitant illness that in the opinion of the investigators will substantially
increase the risk of apheresis or make the volunteer ineligible for study controls are
needed for (eg: active infection, allergies, etc.) |
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| Study is available at: |
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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