LeukopheresisNCT00001349
Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies
An observational study of Leukopheresis and Plasmapheresis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Leukopheresis, Plasmapheresis
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 1993to 9 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any subject enrolled on an existing !RB-approved LPD protocol may be asked to participate and thereby undergo apheresis.
Who may be able to join
- Enrolled on another LPD protocol.
- Weight greater than or equal to 25 kg
- Willingness to participate
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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).
Read the 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.
- Conditions
- Leukopheresis, Plasmapheresis
- Keywords
- Plasmapheresis, Lymphocytes, Eosinophils, Neutrophils
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Donors first admitted to another approved clinical research protocol of the NIAID before having the apheresis procedures described in this protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain leukocytes,platelets, and plasma from subjects already enrolled on other NIAID/LPD protocols.
Leukocytes, platelets, and plasma will be collected.
Measured: Ongoing as this is a method to collect cells from subjects enrolled on other LPD protocols
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start23 Mar 1993
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Why it stopped: Closed at the request of the IRBO
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LeukopheresisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Thomas B Nutman, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001349
- Sponsor's protocol ID
- 930057
- Other IDs
- 93-I-0057
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 1999
- Last updated
- 10 Nov 2021
- Results posted
- No
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.
PubMed 25255226Chatterjee 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.
PubMed 25667413Santiago 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.
PubMed 25404363
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apheresis Procedures to Obtain Plasma or Leukocytes for In Vitro Studies
- ClinicalTrials.gov ID
- NCT00001349
- Acronym / sponsor ID
- 930057
- Conditions
- Leukopheresis, Plasmapheresis
- Keywords
- Plasmapheresis, Lymphocytes, Eosinophils, Neutrophils
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Closed at the request of the IRBO
- Enrolment
- 205 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 23 Mar 1993 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Donors first admitted to another approved clinical research protocol of the NIAID before having the apheresis procedures described in this protocol. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any subject enrolled on an existing !RB-approved LPD protocol may be asked to participate and thereby undergo apheresis.
Key inclusion criteria (3 listed)
- Enrolled on another LPD protocol.
- Weight greater than or equal to 25 kg
- Willingness to participate
Key exclusion criteria (12 listed)
- Age less than 7 years
- Weight less than 25 kg
- Cardiovascular instability
- Hct less than 30
- Inadequate venous access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Leukocytes, platelets, and plasma will be collected.
Results and safety
The study was stopped early (reason given: Closed at the request of the IRBO). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Background: PubMed 25255226Boyd 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.
- Background: PubMed 25667413Chatterjee 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.
- Background: PubMed 25404363Santiago 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas B Nutman, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukopheresis and Plasmapheresis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Closed at the request of the IRBO). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001349, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.