Spleen Size in Peripheral Blood Stem Cell Donors
|First Received Date ICMJE||August 8, 2000|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||August 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00006148 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Spleen Size in Peripheral Blood Stem Cell Donors|
|Official Title ICMJE||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.
|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.|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||June 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00006148|
|Other Study ID Numbers ICMJE||000192, 00-CC-0192|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 2004|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP