ApheresisNCT00562601

LCI Apheresis to Obtain Plasma or White Blood Cells

An observational study of Apheresis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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 than can safely be collected through a simple blood draw or blood donation process. Read more about this study

Who is it for?: Ages 2 years and olderHealthy volunteers can take part
Conditions the study is for: Apheresis
How many people: 864 participants
Where: 1 siteUnited States
Study dates: 28 Mar 1988to 14 Jan 2020
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 2 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

In order to undergo apheresis procedures, patients will be admitted to active clinical research protocols approved by the ICRS. Relatives and normal volunteers may undergo apheresis without first being on an active clinical protocol. Women who are pregnant and normal children will not be studied.
In order to undergo apheresis procedures, as a minimum, patients, family members and control subjects must have a recent history and physical examination, as well as CBC and differential count. Appropriate chemistry and coagulation studies will be performed when clinically indicated. If indicated, a pregnancy test may be performed.
Patients and volunteers undergoing apheresis will be tested against HIV, HBsAg and HCV, if not tested in the previous year.
To be eligible for apheresis for research purposes, children must be at least 7 years old, weigh 25 kilograms, have adequate peripheral access to insert needles for apheresis, and be able to undergo apheresis without sedation. If children between the ages of seven and twelve years are to undergo apheresis, a third party not otherwise involved with the protocol ; e.g., Bioethicist, Patient Advocate, must talk with the child independently to ensure that the child understands the procedure and freely agrees to participate. This protocol alone is not intended for general study of patients, but only as an adjunct protocol to allow for apheresis procedures.
For patients, the following minimal criteria are required to undergo the procedure:
Adequate peripheral venous access;

Show all 17Show fewer

No need for sedation;
Weight greater than 25 kg;
Hematocrit greater than 27%;
Platelet count greater than 75,000/microL;
For patients, the hematological values have to be current (up to a week before the procedure).
Healthy volunteers and relatives will have a CBC performed up to 4 weeks before the procedure. In order to be able to undergo the procedure, they must fulfill all of the below:
Hemoglobin greater than 11 g/dL for males and greater than 10 g/dL for females;
Platelet count greater than 150,000 microL;
WBC greater than 3.5 x 10(3) /microL;
MCV above 80;
Negative HIV, HCV and HBsAg serologies in the past year.

Who cannot join

Patients will not undergo apheresis procedures if they have cardiovascular instability, severe anemia, inadequate venous access, severe coagulation disorder, are pregnant, or have any other condition which the attending physician or Apheresis Clinic staff considers a contraindication to the procedure.
For children, exclusion criteria include age less than 7 years, weigh less than 25 kilograms, inadequate peripheral access to insert needles for apheresis, and unable to undergo apheresis without sedation.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Apheresis Procedures to Obtain Plasma or Leukocytes for In Vitro Studies

Patients 7 years of age and older who are currently enrolled in a NIH clinical research protocol may participate in this study. (Children between the ages of 2 and 6 may participate if they will benefit clinically from undergoing apheresis.) Family members of patients and normal healthy volunteers will also be enrolled.

For all adults and children weighing 55 pounds or more. Blood is drawn through a needle placed in an arm vein and circulated through a cell separator machine. The plasma and white cells are extracted, and the red cells are returned to the donor through a needle in the other arm. The procedure takes from 1 to 2 hours.
For children weighing less than 55 pounds. 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 are separated from the rest of the blood and returned to the donor through the same needle. This procedure requires only one needlestick and takes about 30 to 45 minutes to complete. In some circumstances, the procedure must be repeated one or more times in order to obtain large enough quantities of plasma or cells for study.

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 or leukocytes than can be safely obtained by simple phlebotomy. These components can be easily and safely obtained using apheresis procedures performed in the Apheresis Clinic of the Department of Transfusion Medicine, Clinical Center. This protocol is specifically designed to conform to the requirements of the Apheresis Clinic for donors to have apheresis procedures, but the protocol in itself is not a research protocol. Patients must first be admitted to another approved clinical research protocol of the NIAID before they may have the apheresis procedures described in this protocol. Family members and healthy volunteers may undergo apheresis using only this protocol, without the necessity for entry into any other protocol.

Conditions: Apheresis
Keywords: Leukapheresis, Plasmapheresis, Lymphocytes, Neutrophils

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 198814 Jan 2020

First posted22 Nov 2007 (estimated)
Study start28 Mar 1988
Primary completion14 Jan 2020
Study completion14 Jan 2020

Why it stopped: Closed by the Sponsor/DSMB/IRB

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ApheresisStudies 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
Enrolment: 864 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00562601
Sponsor's protocol ID: 870163
Other IDs: 87-I-0163
Status last verified: Jan 2020
First submitted: 21 Nov 2007
Last updated: 18 Jan 2020
Results posted: No

Publications

Bolan CD, Yau YY, Cullis HC, Horwitz ME, Mackall CL, Barrett AJ, Malech HL, Rehak NN, Wayne AS, Leitman SF. Pediatric large-volume leukapheresis: a single institution experience with heparin versus citrate-based anticoagulant regimens. Transfusion. 2004 Feb;44(2):229-38. doi: 10.1111/j.1537-2995.2004.00668.x.
PubMed 14962314

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
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Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
RecruitingObservational study
Apheresis of Patients With Immunodeficiency
LAD-1, DOCK8
RecruitingObservational study
COLLECT BLOOD/RESEARCH USE
Blood Donors, Research Subjects

All Apheresis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2020. 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: NCT00562601
Acronym / sponsor ID: 870163
Conditions: Apheresis
Keywords: Leukapheresis, Plasmapheresis, Lymphocytes, Neutrophils
Study type: Observational
Recruitment status: TerminatedReason stopped: Closed by the Sponsor/DSMB/IRB
Enrolment: 864 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: 28 Mar 1988 (actual)
Primary completion: 14 Jan 2020 (actual)
Study completion: 14 Jan 2020 (actual)
First posted: 22 Nov 2007 (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.

For all adults and children weighing 55 pounds or more. Blood is drawn through a needle placed in an arm vein and circulated through a cell separator machine. The plasma and white cells are extracted, and the red cells are returned to the donor through a needle in the other arm. The procedure takes from 1 to 2 hours.
For children weighing less than 55 pounds. 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 are separated from the rest of the blood and returned to the donor through the same needle. This procedure requires only one needlestick and takes about 30 to 45 minutes to complete. In some circumstances, the procedure must be repeated one or more times in order to obtain large enough quantities of plasma or cells for study.

Detailed description

Study design

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (17 listed)

In order to undergo apheresis procedures, patients will be admitted to active clinical research protocols approved by the ICRS. Relatives and normal volunteers may undergo apheresis without first being on an active clinical protocol. Women who are pregnant and normal children will not be studied.
In order to undergo apheresis procedures, as a minimum, patients, family members and control subjects must have a recent history and physical examination, as well as CBC and differential count. Appropriate chemistry and coagulation studies will be performed when clinically indicated. If indicated, a pregnancy test may be performed.
Patients and volunteers undergoing apheresis will be tested against HIV, HBsAg and HCV, if not tested in the previous year.
To be eligible for apheresis for research purposes, children must be at least 7 years old, weigh 25 kilograms, have adequate peripheral access to insert needles for apheresis, and be able to undergo apheresis without sedation. If children between the ages of seven and twelve years are to undergo apheresis, a third party not otherwise involved with the protocol ; e.g., Bioethicist, Patient Advocate, must talk with the child independently to ensure that the child understands the procedure and freely agrees to participate. This protocol alone is not intended for general study of patients, but only as an adjunct protocol to allow for apheresis procedures.
Adequate peripheral venous access;

Key exclusion criteria (2 listed)

Patients will not undergo apheresis procedures if they have cardiovascular instability, severe anemia, inadequate venous access, severe coagulation disorder, are pregnant, or have any other condition which the attending physician or Apheresis Clinic staff considers a contraindication to the procedure.
For children, exclusion criteria include age less than 7 years, weigh less than 25 kilograms, inadequate peripheral access to insert needles for apheresis, and unable to undergo apheresis without sedation.

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

Not reported in the source record.

Results and safety

The study was stopped early (reason given: Closed by the Sponsor/DSMB/IRB). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
Background: PubMed 14962314Bolan CD, Yau YY, Cullis HC, Horwitz ME, Mackall CL, Barrett AJ, Malech HL, Rehak NN, Wayne AS, Leitman SF. Pediatric large-volume leukapheresis: a single institution experience with heparin versus citrate-based anticoagulant regimens. Transfusion. 2004 Feb;44(2):229-38. doi: 10.1111/j.1537-2995.2004.00668.x.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.

Related trials for Apheresis

RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
RecruitingObservational study
Apheresis of Patients With Immunodeficiency
LAD-1, DOCK8
RecruitingObservational study
COLLECT BLOOD/RESEARCH USE
Blood Donors, Research Subjects

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.

Adriana R Marques, 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 Apheresis, 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 17 inclusion and 2 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 18 Jan 2020. 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 by the Sponsor/DSMB/IRB). 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00562601, which also lists 1 linked publication.

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 18 Jan 2020.