Spleen Size in Peripheral Blood Stem Cell Donors
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 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.
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.
INCLUSION CRITERIA

 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.

 EXCLUSION CRITERIA

 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.