Apheresis to Obtain Plasma and White Blood Cells in Malies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-20

Study Completion Date

2016-07-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background:

\- Some clinical trials require larger amounts of plasma and white blood cells than can be collected through simple blood donations. Apheresis is a procedure used to collect parts of the blood for study and return the rest of the blood to the donor. Healthy volunteers who provide plasma and white blood cells for study may need to give multiple donations. Researchers want to use apheresis to collect plasma and white blood cells from healthy volunteers in Mali.

Objectives:

\- To collect plasma and white blood cells from healthy volunteers in Mali.

Eligibility:

* Healthy volunteers between 18 and 55 years of age.
* Volunteers must be in National Institute of Allergy and Infectious Diseases clinical trials.

Design:

* Participants will be screened with a physical exam and medical history. They will also provide basic blood and urine samples.
* Participants will have apheresis to collect plasma and white blood cells for study. Before each collection, they will provide a small blood sample for testing. They will be monitored during and after donation to prevent side effects.
* Under this protocol, participants may have apheresis up to six times per year.
* No treatment will be provided as part of this protocol....

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To carry out in vitro research procedures on plasma or leukocyte components of whole 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 a well-established standard apheresis procedure that is in common use at the National Institutes of Health Apheresis Unit. This protocol describes the implementation of the same apheresis procedure at the National Blood Transfusion Center in Bamako, Mali. This is not a research protocol per se, but rather an adjunct protocol which allows healthy donors 18-55 years of age to undergo apheresis. Subjects must already be enrolled in another protocol which has been approved by the National Institute of Allergy and Infectious Diseases Institutional Review Board and the Faculty of Medicine, Pharmacy, and Odonto-Stomatology Ethics Committee.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malaria

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Apheresis Leukocytes Plasma Plamodium Falciparum Malaria Immunology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Individuals 18-55 years of age are eligible to enter the study if they:

* Are enrolled on another NIAID/FMPOS-approved protocol.
* Weigh greater than or equal to 50 kg.
* Agree to have blood specimens stored for future studies.
* Agree to undergo genetic testing.
* Agree to undergo HIV, hepatitis B, and hepatitis C virus testing.

Exclusion Criteria

The following criteria are exclusionary:

* Positive at screening for HIV, hepatitis B, and/or hepatitis C.
* Cardiovascular instability (blood pressure \<90/50 or \>180/100; pulse \<40 or \>110.
* Inadequate peripheral venous access.
* Anemia (hemoglobin \<11 g/dL).
* Current use of corticosteroids or other immunosuppressants.
* Underlying heart disease, lung disease, bleeding disorder, or other conditions that, in the judgment of the investigator, contraindicates apheresis.
* Temperature greater than or equal to 37.5 degree C or other clinical evidence of an acute infection.
* Currently pregnant or breastfeeding.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter D Crompton, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Allergy and Infectious Diseases (NIAID)

Countries

Review the countries where the study has at least one active or historical site.

Mali

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-I-N048

Identifier Type: -

Identifier Source: secondary_id

999912048