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Clinical Trial: Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studiess
This study is currently recruiting patients.
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Purpose
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 than 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.
MedlinePlus consumer health information
Study Type: Observational
Study Design: Natural History
Official Title: Apheresis Procedures to Obtain Plasma or Lymphocytes for In Vitro Studies
Further Study Details:
Expected Total Enrollment: 2400
Study start: October 19, 1981
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. This protocol is specifically designed to conform to the requirements of the Apheresis Unit for donors to have apheresis procedures, but the protocol, by itself, is not an independent research study.
Eligibility
Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
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
Adequate blood counts (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 normal healthy 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
Currently abusing alcohol or other drugs
Any medical condition for which the PI feels apheresis might be contraindicated
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00114647
Maryland
National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pike, Bethesda, Maryland, 20892, United States; Recruiting
Patient Recruitment and Public Liaison Office 1-800-411-1222 prpl@mail.cc.nih.gov
TTY 1-866-411-1010
TTY 1-866-411-1010
More Information
Detailed Web Page
Publications
Malaspina A, Moir S, Kottilil S, Hallahan CW, Ehler LA, Liu S, Planta MA, Chun TW, Fauci AS. Deleterious effect of HIV-1 plasma viremia on B cell costimulatory function. J Immunol. 2003 Jun 15;170(12):5965-72.
Moir S, Ogwaro KM, Malaspina A, Vasquez J, Donoghue ET, Hallahan CW, Liu S, Ehler LA, Planta MA, Kottilil S, Chun TW, Fauci AS. Perturbations in B cell responsiveness to CD4+ T cell help in HIV-infected individuals. Proc Natl Acad Sci U S A. 2003 May 13;100(10):6057-62. Epub 2003 May 01.
Migueles SA, Laborico AC, Shupert WL, Sabbaghian MS, Rabin R, Hallahan CW, Van Baarle D, Kostense S, Miedema F, McLaughlin M, Ehler L, Metcalf J, Liu S, Connors M. HIV-specific CD8+ T cell proliferation is coupled to perforin expression and is maintained in nonprogressors. Nat Immunol. 2002 Nov;3(11):1061-8. Epub 2002 Oct 7.
Study ID Numbers: 810164; 81-I-0164
Record last reviewed: October 27, 2004
Last Updated: June 15, 2005
Record first received: June 15, 2005
ClinicalTrials.gov Identifier: NCT00114647
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-21
Record last reviewed: October 27, 2004
Last Updated: June 15, 2005
Record first received: June 15, 2005
ClinicalTrials.gov Identifier: NCT00114647
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-21
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