Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00031291 · ClinicalTrials.gov registry record
Plasmapheresis of Anthrax-Vaccinated Subjects for Production of Anthrax Immune Globulin
A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 400
- Enrollment target
NCT00031291 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 400 participants.
The verdict
NCT00031291 has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 400 participants
- Enrollment target
Study Summary
This protocol is a joint project of the National Institutes of Health, the Centers for Disease Control and the United States Army Medical Research Institute for Infectious Diseases. It is designed to collect plasma from healthy employees of the Department of Defense who have been vaccinated against anthrax. The collected plasma will be pooled to make an anthrax-fighting antibody solution called anthrax immune globulin intravenous (AIGIV). This solution will be used for: * Animal experiments to test its effectiveness in preventing the development of anthrax after inhalation exposure; * Treating people severely ill with anthrax who are not improving with standard antibiotic therapy; and * Treating people exposed to spores of the bacteria that cause anthrax to try to prevent development of the disease. Healthy volunteers between 18 and 65 years of age who have received at least four doses of the anthrax vaccine and who meet the criteria for blood donors may be eligible to participate in this study. Volunteers will be recruited from Department of Defense civilian and military employees. Candidates will be screened with an interview and blood tests. Participants will undergo the following procedures: * Have a health history screen for donating plasma * Measurement of heart rate, blood pressure and temperature * Fingerstick to check hemoglobin level * Blood tests for HIV, hepatitis B and C, syphilis and other infectious diseases * Blood test for anthrax antibody levels * Plasmapheresis to collect blood plasma (the liquid part of the blood) In plasmapheresis, whole blood is drawn through a needle placed in an arm vein. The blood flows into a cell separator machine, where it is spun to separate the plasma from the blood cells. The plasma is collected in a plastic bag in the machine, while the rest of the blood is returned to the donor through the needle in the arm. During the procedure, the donor is given a blood thinner called citrate to prevent the blood from clottin
Interventions
- DRUG Anthrax Immune Globulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2002-02 |
| Est. Completion | 2004-03 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00031291
The ClinicalTrials.gov registry entry for NCT00031291 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Anthrax Immune Globulin is the first listed.
NCT00031291 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00031291 about?
NCT00031291 is a clinical study titled "Plasmapheresis of Anthrax-Vaccinated Subjects for Production of Anthrax Immune Globulin". This protocol is a joint project of the National Institutes of Health, the Centers for Disease Control and the United States Army Medical Research Institute for Infectious Diseases. It is designed to collect plasma from healthy employees of the Department of Defense who have been vaccinated against ...
What is the current status of trial NCT00031291?
This trial is currently completed. The enrollment target is 400 participants. The study started on 2002-02. Estimated completion is 2004-03.
What interventions are being tested in trial NCT00031291?
The interventions under investigation include: Anthrax Immune Globulin (DRUG).
Who is sponsoring clinical trial NCT00031291?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.