Spleen Size in Peripheral Blood Stem Cell Donors
|ClinicalTrials.gov Identifier: NCT00006148|
Recruitment Status : Completed
First Posted : August 9, 2000
Last Update Posted : March 4, 2008
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||49 participants|
|Official Title:||Spleen Size in Peripheral Blood Stem Cell Donors|
|Study Start Date :||August 2000|
|Estimated Study Completion Date :||June 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006148
|United States, Maryland|
|Warren G. Magnuson Clinical Center (CC)|
|Bethesda, Maryland, United States, 20892|