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NCT00001846 · ClinicalTrials.gov registry record
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
A clinical trial of Blood Donors and Research Subjects, sponsored by National Institutes of Health Clinical Center (CC).
- Recruiting
- Registry status
- 5,000
- Enrollment target
- 1
- Study location
NCT00001846: Recruiting study of Blood Donors and Research Subjects, sponsored by National Institutes of Health Clinical Center (CC).
NCT00001846 is a study of Blood Donors and Research Subjects that is actively recruiting participants, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 5,000 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001846, a study of Blood Donors and Research Subjects, is actively recruiting participants, sponsored by National Institutes of Health Clinical Center (CC).
- RECRUITING
- Registry status
- 5,000 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
Provision of samples to researchers
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,000 participants |
| Start Date | 2001-01-11 |
What NCT00001846 shows while recruiting
NCT00001846 is an observational study that tracks outcomes without assigning an intervention. Its 5,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 3 conditions, with Blood Donors appearing as the primary indexed condition, and to 0 interventions.
NCT00001846 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001846 about?
NCT00001846 is a clinical study titled "Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use". 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 re...
What is the current status of trial NCT00001846?
This trial is currently recruiting. The enrollment target is 5,000 participants. The study started on 2001-01-11.
What conditions does trial NCT00001846 study?
This clinical trial studies the following conditions: Blood Donors, Research Subjects, Apheresis.
Who is sponsoring clinical trial NCT00001846?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001846 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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