Whole Blood and Blood Component Collection for Research

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001846
First received: November 3, 1999
Last updated: March 14, 2014
Last verified: January 2014
  Purpose

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 A needle is placed in an arm vein and a unit of blood (about 400 to 500 ml, or 30 tablespoons) is withdrawn into a plastic bag or several tubes.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


Condition
Healthy

Study Type: Observational
Official Title: Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 5000
Study Start Date: August 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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, and donors who have had sexual contact within the past 12 months with a person who has symptomatic hepatitis C infection are similarly eligible for research-use only donation on this protocol.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001846

Contacts
Contact: Amy Melpolder (301) 496-0092 amelpolder@mail.cc.nih.gov
Contact: Kathleen A Cantilena (301) 451-8637 ccantilena@mail.nih.gov

Locations
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    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Kathleen A Cantilena National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00001846     History of Changes
Other Study ID Numbers: 990168, 99-CC-0168
Study First Received: November 3, 1999
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Volunteer Donor
Research Samples
Leukapheresis
Plateletpheresis
Plasmapheresis
Healthy Volunteer
Normal Volunteer

ClinicalTrials.gov processed this record on August 28, 2014