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Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 289 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Eligibility criteria expanded, about 1 word

    Publications: details revised at 3 of 3 entries

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: 18 years of age or older Adequate venous [...]

  2. Minor

    30 amendments

    30 re-verifications since 2025-05-30, no change to tracked fields

    v259-v288

  3. Minor

    Eligibility criteria expanded, about 1 word

    Show what changed: Eligibility criteria
    [...] for which the PI feels apheresis or other sample collection proceduresmightprocedures might be contraindicated

    Study Status, Eligibility, Contacts/Locationsv258

  4. Minor

    18 amendments

    18 re-verifications since 2025-02-20, no change to tracked fields

    v240-v257

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00114647
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Healthy Volunteers, HIV
Enrollment 3,000 participants
Start Date
Updated on ClinicalTrials.gov