Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies
NCT ID: NCT00001349
Last Updated: 2021-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
205 participants
OBSERVATIONAL
1993-03-23
2021-11-09
Brief Summary
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Patients 7 years of age and older with a parasitic infection or condition associated with a parasitic infection (i.e., elevated levels of IgE antibodies or of a type of white cell called eosinophils) who are currently enrolled in a NIH clinical research protocol may be eligible for this study. Relatives of patients and normal healthy volunteers will also be enrolled. Candidates will have a medical history, physical examination and blood tests. Individuals weighing less than 25 kilograms (55 pounds) may not participate.
Participants will undergo one of the following two apheresis procedures:
* Automated pheresis Whole 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 a needle in the other arm. The procedure takes 1 to 2 hours.
* Manual pheresis Whole blood is drawn through a needle placed in an arm vein and circulated through the cell separator machine. The red blood cells are separated from the rest of the blood and returned to the donor through the same needle. Usually only one needle stick is required and the procedure takes from 30 to 45 minutes. This method is used only in individuals who weigh less than 35 kg (77 pounds).
Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
OTHER
Study Groups
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1
Donors first admitted to another approved clinical research protocol of the NIAID before having the apheresis procedures described in this protocol.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Weight greater than or equal to 25 kg
* Willingness to participate
Exclusion Criteria
* Weight less than 25 kg
* Cardiovascular instability
* Hct less than 30
* Inadequate venous access
* PTT or PT greater than 1.5 normal
* Pregnancy
* Women who are actively breastfeeding
* Other condition which the attending physician or Apheresis Unit staff considers a contraindication to the procedure
* For Hetastarch procedure
* Hypertension
* Evidence of fluid retention
8 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Thomas B Nutman, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
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References
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Boyd A, Ribeiro JM, Nutman TB. Human CD117 (cKit)+ innate lymphoid cells have a discrete transcriptional profile at homeostasis and are expanded during filarial infection. PLoS One. 2014 Sep 25;9(9):e108649. doi: 10.1371/journal.pone.0108649. eCollection 2014.
Chatterjee S, Clark CE, Lugli E, Roederer M, Nutman TB. Filarial infection modulates the immune response to Mycobacterium tuberculosis through expansion of CD4+ IL-4 memory T cells. J Immunol. 2015 Mar 15;194(6):2706-14. doi: 10.4049/jimmunol.1402718. Epub 2015 Feb 9.
Santiago Hda C, Ribeiro-Gomes FL, Bennuru S, Nutman TB. Helminth infection alters IgE responses to allergens structurally related to parasite proteins. J Immunol. 2015 Jan 1;194(1):93-100. doi: 10.4049/jimmunol.1401638. Epub 2014 Nov 17.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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93-I-0057
Identifier Type: -
Identifier Source: secondary_id
930057
Identifier Type: -
Identifier Source: org_study_id