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NCT00006148 · ClinicalTrials.gov registry record

Spleen Size in Peripheral Blood Stem Cell Donors

A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).

Completed
Registry status
49
Enrollment target

NCT00006148 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 49 participants.

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The verdict

NCT00006148 has completed, sponsored by National Institutes of Health Clinical Center (CC).

COMPLETED
Registry status
49 participants
Enrollment target

Study Summary

This study will determine whether the spleen in people who donate stem cells (bone marrow cells collected from the blood) enlarges as a result of taking granulocyte colony-stimulating factor (G-CSF). Donors take this growth factor to maximize the amount of stem cells that can be collected for transplantation to patients with leukemia or other diseases. The study will also examine whether changes in the donor's white blood cell count, blood stem cell count, and blood chemistries can predict a change in spleen size. Stem cells donors take G-CSF for 5 to 6 days before donating. Besides increasing the number of stem cells and white blood cells in the bloodstream, the drug also causes some other temporary changes in blood chemistry. Many people who take G-CSF for a few days get a headache, feel an ache in their bones, or feel tired for a few days. About one-third of patients chronically treated with G-CSF to raise blood cell counts develop an enlarged spleen. It is not known if a brief 5- to 6-day course of G-CSF also affects the size of the spleen, but about 1 in 10,000 blood stem cell donors have had a spontaneous rupture of the spleen. Adults and children 18 years of age and older who are donating stem cells for relatives enrolled in clinical trials at the National Institutes of Health may participate in this study. They will donate stem cells according to the standard procedure, but will give an extra 15 milliliters (3 teaspoons) of blood both before receiving G-CSF and after donating stem cells. Donors' spleen size will be measured by ultrasound scanning of the abdomen three times: the day before receiving G-CSF, the day after donating the stem cells and 4 days after donating.

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2000-08
Est. Completion 2004-06

What the Registry Record Tells You About NCT00006148

The ClinicalTrials.gov registry entry for NCT00006148 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 49 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 0 interventions.

NCT00006148 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00006148 about?

NCT00006148 is a clinical study titled "Spleen Size in Peripheral Blood Stem Cell Donors". This study will determine whether the spleen in people who donate stem cells (bone marrow cells collected from the blood) enlarges as a result of taking granulocyte colony-stimulating factor (G-CSF). Donors take this growth factor to maximize the amount of stem cells that can be collected for transp...

What is the current status of trial NCT00006148?

This trial is currently completed. The enrollment target is 49 participants. The study started on 2000-08. Estimated completion is 2004-06.

Who is sponsoring clinical trial NCT00006148?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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