NIH Clinical Research Studies

Protocol Number: 99-CC-0168

Active Accrual, Protocols Recruiting New Patients

Title:
Collection and Distribution of Blood Components from Healthy Donors for In Vitro Research Use
Number:
99-CC-0168
Summary:
This protocol is designed to collect whole blood and blood components for National Institutes of Health (NIH) research. Blood samples from healthy, normal donors are used in a myriad of laboratory experiments ranging from preparing vaccines and testing the effectiveness of new drugs to detecting genetic causes of diseases and studying the structure and function of blood components. Participants in this protocol may be asked to donate whole blood or blood components through the following collection procedures:

Whole Blood: Whole blood donors have their pulse, blood pressure, and temperature taken and answer questions about their health and medical history. The donor then lies on a recliner or couch. A needle is placed in an arm vein and a unit of blood (about 400 to 500 ml, or 30 tablespoons) is withdrawn into a plastic bag or several tubes. The entire process takes about 10 to 15 minutes.

Blood Components: Donors of blood components (white cells, platelets, and plasma) answer questions about their health and medical history and have their pulse, blood pressure and temperature taken. Blood components are collected in a procedure called apheresis, described below. White cell collection is called leukapheresis; platelet collection is called plateletpheresis, and plasma collection is called plasmapheresis.

In leukapheresis, whole blood is drawn through a needle in one arm and flows into a cell separator machine, where it is spun very fast to separate the cells. The needed component is collected in a plastic bag in the machine, while the rest of the blood is returned to the donor either through the same needle or through a needle in the other arm. During the procedure, the donor is given a blood thinner called citrate to prevent the blood from clotting while it is in the cell separator. The procedure may last from 1 to 3 hours, depending on how many cells are collected. Only a small fraction of the body's total cells are removed. The body quickly replaces them, and their loss does not affect the donor's health. To collect a particular type of white cell called granulocytes, a substance called hextastarch is added to the citrate to increase the number of cells collected. Granulocyte donors may also be asked to take a steroid the night before the procedure to increase the white cell count in the blood by the time of collection. Plasmapheresis and plateletpheresis are performed the same way as leukapheresis, except that the plasma or platelets are removed and the remaining parts of the blood returned.

Sponsoring Institute:
Warren G. Magnuson Clinical Center (CC)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Donors must meet all eligibility criteria for volunteer whole blood donation as defined in the Standards of the AABB2 and the Code of Federal Regulations 21 CFR 640.3 Specific criteria include:

Age greater than 17 and less than 85 years old.

Weight greater than 110 pounds.

EXCLUSION CRITERIA:

No known heart, lung, kidney disease, or bleeding disorders.

No history of hepatitis since age 11.

No history of intravenous injection drug use.

No history of engaging in high-risk activities for exposure to the AIDS virus, as defined in the DTM "Donor Alert."

Granulocyte donors can not have hypertension or diabetes.

Female subjects should not be pregnant.

Special Instructions:
This is a paid, volunteer blood donor study.
Keywords:
Volunteer Donor
Research Samples
Leukapheresis
Plateletpheresis
Plasmapheresis
Recruitment Keywords:
Healthy Volunteer
Normal Volunteer
Conditions:
Healthy
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Frequency of immediate adverse effects associated with apheresis donation

Active Accrual, Protocols Recruiting New Patients

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Clinical Center LogoWarren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/16/2004

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