Whole Blood and Blood Component Collection for Research
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 A needle is placed in an arm vein and a unit of blood (about 400 to 500 ml, or 30 tablespoons) is withdrawn into a plastic bag or several tubes.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.
|Official Title:||Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use|
|Study Start Date:||August 1999|
This protocol is designed to provide a mechanism for the Department of Transfusion Medicine, Clinical Center to collect and process blood components from paid, healthy volunteer donors for distribution to NIH intramural investigators for in vitro research use. Donors meeting research donor eligibility criteria will be recruited to donate blood and blood components by standard phlebotomy and apheresis techniques. The investigational nature of the studies in which their blood will be used, and the risks and discomforts of the donation process will be carefully explained to the donors, and a signed informed consent document will be obtained. Donors will be compensated according to an established schedule based on the duration and discomfort of the donation. NIH investigators requesting blood components for research use will be required to submit an electronic (Web-based) memo of request, briefly describing the nature of the research, and providing assurance that samples provided through this protocol will be used solely for in vitro and not for in vivo research. This protocol also provides a detailed schema for careful and frequent laboratory safety monitoring of repeat research apheresis donors.
Blood components for research use will be distributed with a unique product number, and the DTM principal and associate investigators will serve as the custodians of the code that links the product with a donor's identity. The nature of the in vitro studies in which the blood and components collected in this study will be used is not the subject of this protocol, and is not possible to describe, since it involves basic investigative efforts in greater than 100 different NIH laboratories. The intent of this protocol is not to approve the research itself, but to provide adequate and complete informed consent for the donor, and to assure that the education, counseling, and protection of the study subjects (research blood donors) is performed in accordance with IRB, OHSR, OPRR and other applicable Federal regulatory standards.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001846
|Contact: Amy Melpolder||(301) email@example.com|
|Contact: Kathleen A Cantilena, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Kathleen A Cantilena, M.D.||National Institutes of Health Clinical Center (CC)|