- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01094197
Detailed Evaluation of Microchimerism
Evaluation to Determine Whether Transfusion-associated Microchimerism Involves Engraftment With Hematopoietic Progenitor Cells
Study Overview
Status
Detailed Description
Transfusion-associated microchimerism, the persistence of donor white blood cells months or years after transfusion in the recipient, has been observed in approximately 10-15% of transfused trauma patients. Previous studies suggest that the microchimeric cells include multiple immunophenotypes of leukocytes (CD4+, CD8+, CD15+, and CD19+) and that they can persist for decades, features suggestive of hematopoietic engraftment.
In this study, ten subjects known to have long-term microchimerism will undergo either leukapheresis (a blood filtering procedure) or collection of a 500 mL whole blood sample (the amount of a standard blood donation). These samples will then be analyzed to determine whether the microchimeric (donor) cells include hematopoietic stem cells (CD34+) and precursor cells in the red blood cell, white blood cell, and platelet lineages.
Study Type
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States, 95817
- University of California, Davis, Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Demonstrated long-term microchimerism following transfusion for traumatic injury
Exclusion Criteria:
- Prior bone marrow or solid organ transplantation
- Pregnancy
- Blood transfusion within the past 12 months
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Transfused microchimeric subject
Former trauma patient who underwent blood transfusion and has recent evidence of long-term transfusion-associated microchimerism
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael P. Busch, MD, PhD, Blood Systems Research Institute
Publications and helpful links
General Publications
- Utter GH, Owings JT, Lee TH, Paglieroni TG, Reed WF, Gosselin RC, Holland PV, Busch MP. Blood transfusion is associated with donor leukocyte microchimerism in trauma patients. J Trauma. 2004 Oct;57(4):702-7; discussion 707-8. doi: 10.1097/01.ta.0000140666.15972.37.
- Lee TH, Paglieroni T, Utter GH, Chafets D, Gosselin RC, Reed W, Owings JT, Holland PV, Busch MP. High-level long-term white blood cell microchimerism after transfusion of leukoreduced blood components to patients resuscitated after severe traumatic injury. Transfusion. 2005 Aug;45(8):1280-90. doi: 10.1111/j.1537-2995.2005.00201.x.
- Utter GH, Reed WF, Lee TH, Busch MP. Transfusion-associated microchimerism. Vox Sang. 2007 Oct;93(3):188-95. doi: 10.1111/j.1423-0410.2007.00954.x.
- Utter GH, Lee TH, Rivers RM, Montalvo L, Wen L, Chafets DM, Reed WF, Busch MP. Microchimerism decades after transfusion among combat-injured US veterans from the Vietnam, Korean, and World War II conflicts. Transfusion. 2008 Aug;48(8):1609-15. doi: 10.1111/j.1537-2995.2008.01758.x. Epub 2008 May 22.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 695
- 1R01HL083388 (U.S. NIH Grant/Contract)
- R01HL083388 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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