Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies
November 9, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
Apheresis Procedures to Obtain Plasma or Leukocytes for In Vitro Studies
This study will collect blood plasma and white blood cells for laboratory research 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.
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).
Study Overview
Status
Terminated
Conditions
Detailed Description
In order to carry out in vitro research procedures on the plasma or leukocyte components of blood, it is often necessary to obtain larger quantities of plasma and/or leukocytes, 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 (>7 years of age and greater than or equal to 25kg).
Donors must first be admitted to another approved clinical research protocol of the LPD, NIAID before they may have the apheresis procedures described in this protocol.
The investigational nature of the studies in which the samples will be used, as well as the risks and benefits of the donation process will be explained to all donors, and a signed informed consent document will be obtained.
Study Type
Observational
Enrollment (Actual)
205
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Any subject enrolled on an existing !RB-approved LPD protocol may be asked to participate and thereby undergo apheresis.
Description
- INCLUSION CRITERIA:
- Enrolled on another LPD protocol.
- Weight greater than or equal to 25 kg
- Willingness to participate
EXCLUSION CRITERIA:
- Age less than 7 years
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To obtain leukocytes,platelets, and plasma from subjects already enrolled on other NIAID/LPD protocols.
Time Frame: Ongoing as this is a method to collect cells from subjects enrolled on other LPD protocols
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Leukocytes, platelets, and plasma will be collected.
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Ongoing as this is a method to collect cells from subjects enrolled on other LPD protocols
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 23, 1993
Primary Completion (Actual)
November 9, 2021
Study Completion (Actual)
November 9, 2021
Study Registration Dates
First Submitted
November 3, 1999
First Submitted That Met QC Criteria
November 3, 1999
First Posted (Estimate)
November 4, 1999
Study Record Updates
Last Update Posted (Actual)
November 10, 2021
Last Update Submitted That Met QC Criteria
November 9, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 930057
- 93-I-0057
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.