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Spleen Size in Peripheral Blood Stem Cell Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006148
Recruitment Status : Completed
First Posted : August 9, 2000
Last Update Posted : March 4, 2008
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief 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.

Condition or disease

Detailed Description:
The administration of granulocyte-colony stimulating factor (G-CSF) leads to splenic enlargement in approximately one third of neutropenic patients who are chronically treated with this drug. Short courses, 5 to 6-days, of G-CSF are used to increase the yield of hematopoietic progenitor cells collected by apheresis from peripheral blood stem cell (PBSC) donors. G-CSF mobilized PBSC concentrates are increasingly replacing marrow as a source of hematopoietic progenitor cells for transplants involving HLA-compatible relatives. PBSC donors experience splenomegaly and rarely, spontaneous rupture of the spleen. Since splenomegaly is a risk factor for splenic rupture, it is important to determine the incidence and time course of splenic enlargement in PBSC concentrate donors. This protocol will prospectively study 40 subjects donating G-CSF mobilized PBSC for HLA compatible relatives or donating PBSC's for laboratory investigations at the Department of Transfusion Medicine in the Warren G. Magnuson Clinical Center. The subjects will be given G-CSF for 5 days and a PBSC concentrate will be collected on day 5. Ultrasound scans will be used to assess their spleen size. The scans will be performed before G-CSF administration and the day the last PBSC concentrate is collected. A third scan will be performed 10 or 11 days after the last PBSC is collected. The effects of several parameters on spleen size will be assessed including: donor age, gender, race and changes in liver function assays, white blood cell counts, platelet counts, and CD34+ cell counts.

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Study Type : Observational
Enrollment : 49 participants
Official Title: Spleen Size in Peripheral Blood Stem Cell Donors
Study Start Date : August 2000
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Adults and children 18 years of age or greater will be studied.

Enrolled in a primary stem cell transplant protocol that has been approved by the IRB.

Potential subjects are people donating PBSC concentrates for HLA-compatible relatives as part of IRB approved protocols or donating PBSCs for laboratory investigations.


Donors who cannot remain in the Bethesda area for an additional 4 to 5 days following their donations will be excluded from the third ultrasound.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006148

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United States, Maryland
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)

Layout table for additonal information Identifier: NCT00006148    
Other Study ID Numbers: 000192
First Posted: August 9, 2000    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: June 2004
Keywords provided by National Institutes of Health Clinical Center (CC):
Granulocyte Colony - Stimulation Factor
Peripheral Blood Stem Cells
Additional relevant MeSH terms:
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Pathological Conditions, Anatomical