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NCT00040235 · ClinicalTrials.gov registry record · Phase 3
Magnesium Effects in Apheresis
A Phase 3 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 3
- Development phase
- 52
- Enrollment target
NCT00040235: Completed Phase 3 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT00040235 is a Phase 3 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 52 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00040235, a Phase 3 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 52 participants
- Enrollment target
Study Summary
This study will determine whether magnesium replacement during apheresis can decrease side effects that donors commonly experience. Apheresis is a method of collecting large numbers of certain blood cells, such as white cells, stem cells, or platelets. In this procedure, whole blood is collected through a needle in an arm vein, similar to donating blood. The blood is separated into its components by centrifugation (spinning), the required cells are extracted, and the rest of the blood is returned to the body, either through the same needle or through another needle in the other arm. When healthy people donate cells by apheresis, a blood thinner called citrate is added to prevent the blood from clotting in the apheresis machine. Citrate works by reducing calcium in the blood. When the blood is returned to the donor, citrate from the machine is also returned, lowering the donor's calcium levels. As a result, donors often feel tingling around the mouth, hands, and feet. Some of these symptoms can be prevented by giving calcium intravenously (through a vein) during the procedure. Even with the added calcium, however, some donors still have symptoms. Magnesium levels are also lowered by citrate, but it is not known if this causes symptoms. This study will examine whether the decrease in magnesium levels also contributes to the side effects of apheresis and whether magnesium replacement can reduce these symptoms. Healthy apheresis donors 18 years of age or older who are enrolled in NIH protocols may participate in this study. Donors will undergo the apheresis procedures required by the NIH protocol they are enrolled in. Throughout the procedure, they will receive an intravenous infusion of a salt solution that may or may not contain magnesium. Blood samples of 5 milliliters (1 teaspoon) each will be taken from the apheresis machine at the beginning and end of the procedure and at 30- to 60-minute intervals during the procedure. No more than 50 ml (3 tablespoons) will b
Interventions
- PROCEDURE magnesium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2002-06 |
| Est. Completion | 2004-02 |
| Phase | Phase 3 |
What the finished NCT00040235 record still lists
NCT00040235 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which magnesium is the first listed.
NCT00040235 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00040235 about?
NCT00040235 is a clinical study titled "Magnesium Effects in Apheresis". This study will determine whether magnesium replacement during apheresis can decrease side effects that donors commonly experience. Apheresis is a method of collecting large numbers of certain blood cells, such as white cells, stem cells, or platelets. In this procedure, whole blood is collected thr...
What is the current status of trial NCT00040235?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2002-06. Estimated completion is 2004-02.
What interventions are being tested in trial NCT00040235?
The interventions under investigation include: magnesium (PROCEDURE).
Who is sponsoring clinical trial NCT00040235?
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
How this trial's enrollment target compares
Where NCT00040235's enrollment target sits among peer trials
52 1841st of 2000 higher than 159 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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