Clinical trial NCT01511601: Apheresis to Obtain Plasma and White Blood Cells in Malies
Official title: Apheresis to Obtain Plasma and Leukocytes in Mali for In Vitro Studies
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Malaria
Keywords: Apheresis
Leukocytes
Plasma
Plamodium Falciparum Malaria
Immunology
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2012-01-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: 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: 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.

Eligibility criteria: * 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Peter D Crompton, M.D.
role: PRINCIPAL_INVESTIGATOR
References: