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Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 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: December 1, 2016
Last verified: November 2016
  Purpose

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 and FDA researchers for in vitro laboratory 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 and FDA 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 170 different NIH and FDA 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


Condition
Blood Donors
Research Subjects
Apheresis

Study Type: Observational
Study Design: Time Perspective: Prospective
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):

Primary Outcome Measures:
  • Provision of samples to researchers [ Time Frame: Quarterly ] [ Designated as safety issue: No ]

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

Background:

-NIH and FDA intramural investigators performing in vitro studies involving human blood components have a need for a steady, reliable, consistent source of these blood components, preferably derived from screened donors documented to be free of potential transfusiontransmissible diseases.

Objectives:

  • To provide a mechanism, that is reviewed and approved by IRB, for the Department of Transfusion Medicine, Clinical Center to collect and process blood and blood components from paid, healthy volunteer donors for distribution to NIH intramural investigators and FDA laboratories for in vitro research use.
  • To provide adequate and complete informed consent to the donors of research blood samples, and to assure that the education, counseling, and protection of the study subjects (research blood donors) from research risks is performed in accordance with IRB, OPRR and other applicable Federal regulatory standards.

Eligibility:

Donors must meet the eligibility criteria for volunteer whole blood donation with the exception of foreign travel history and other requirements, some of which are outlined below:

  • Age greater than or equal to 18 years
  • Weight greater than 110 pounds
  • No known heart, lung, kidney disease, or bleeding disorders
  • No history of sickle cell disease
  • No history of hepatitis since age 11
  • Female subjects should not be pregnant

Design:

  • 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 and FDA 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.
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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 Conry Cantilena, M.D. (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
National Institutes of Health Clinical Center (CC)
Investigators
Principal Investigator: Kathleen A Conry Cantilena, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
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: December 1, 2016
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 December 02, 2016