Apheresis to Obtain Plasma and Leukocytes in Mali for In Vitro Studies
试验速览
研究概览
简要总结
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....
详细描述
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供