Apheresis to Obtain Plasma and White Blood Cells in Malies

ID: NCT01511601
Status: Withdrawn
Phase: N/A
Start Date: December 20, 2011
First Submitted: January 13, 2012
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Location: N/A
Conditions: Malaria
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Study Description

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.
Condition or disease Intervention/treatment Phase

Malaria

N/A

Tracking Information

First Submitted DateJanuary 13, 2012
Last Update Posted DateFebruary 22, 2018
Start DateDecember 20, 2011
Completion DateJuly 28, 2016
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

Not Available

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleApheresis to Obtain Plasma and White Blood Cells in Malies
Official TitleApheresis to Obtain Plasma and Leukocytes in Mali for In Vitro Studies
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.

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
0
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Malaria
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Not Available
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Withdrawn
Enrollment0
Completion DateJuly 28, 2016
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.
GenderAll
Age18 Years to 55 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Mali

Administrative Information

NCT Number:NCT01511601
Other Study ID Numbers
999912048
12-I-N048
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Not Available
Investigators
Principal Investigator
Peter D Crompton, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)