Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT00114647
Collaborator
(none)
3,000
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Procedures to Obtain Plasma, Lymphocytes, or Other Specimens for Research Studies
    Actual Study Start Date :
    Jan 9, 1984

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Healthy Volunteers

    2

    HIV

    Outcome Measures

    Primary Outcome Measures

    1. Specimen collection for the study of infectious diseases [Ongoing]

      Collection of specimens for the study of infectious diseases.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • 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 women

    Currently abusing alcohol or other drugs

    Any medical condition for which the PI feels apheresis or other sample collection proceduresmight be contraindicated

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Principal Investigator: Richard T Davey, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT00114647
    Other Study ID Numbers:
    • 810164
    • 81-I-0164
    First Posted:
    Jun 16, 2005
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Jul 5, 2022
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)

    Study Results

    No Results Posted as of Aug 19, 2022