Protocol Number: 99-CC-0168

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 A needle is placed in an arm vein and a unit of blood (about 400 to 500 ml, or 30 tablespoons) is withdrawn into a plastic bag or several tubes.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:

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled

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, with the exception of foreign travel history and other disorders as noted below. Specific criteria include:

Age greater than or equal to 18 years.

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 in the past 5 years.

No receipt of clotting factor concentrates in the past 5 years.

No receipt of money or drugs in exchange for sex in the past 5 years.

No history of engaging in high-risk activities for exposure to the AIDS virus, as defined in the AABB Donor Education Materials distributed to all donors. (Granulocyte donors may not receive dexamethasone if they have poorly controlled hypertension or diabetes, or if they have a history of cataracts. Hetastarch and dexamethasone may elevate blood pressure and raise blood glucose levels, and repetitive steroid administration may increase the risk of posterior subcapsular cataract formation or progression. Granulocyte donors may not receive filgrastim if they have a history or symptoms of coronary heart disease).

Granulocyte donors can not have hypertension or diabetes.

Female subjects should not be pregnant.

NOTE: Donors who have traveled to Europe, Africa, Asia, and areas of South America that render them ineligible for allogeneic donation due to malarial risk and vCJD hypothetical risk, are eligible for research donations. Donors with a history of Chagas disease, babesiosis, or malaria, donors who have a family history of CJD, donors who have undergone tattooing or body piercing within the prior 12 months, donors who have received a dura mater graft, and donors who are taking finasteride or retinoids, are similarly eligible for research-use only donation on this protocol.

Special Instructions:

This is a paid, volunteer blood donor study.

Keywords:

Volunteer Donor

Research Samples

Leukapheresis

Plateletpheresis

Plasmapheresis

Recruitment Keyword(s):

Healthy Volunteer

Normal Volunteer

Condition(s):

Healthy

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

Warren G. Magnuson Clinical Center

Contact(s):

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

Citation(s):

Frequency of immediate adverse effects associated with apheresis donation

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 09/16/2008