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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00400192 |
Individuals who experience a traumatic injury often have a significant amount of blood loss and may require a blood transfusion. In some individuals who receive a blood transfusion, white blood cells from the donor's blood may remain in the body for years, a condition known as microchimerism. This study will examine the reasons why microchimerism occurs in some blood transfusion recipients and not others.
Condition |
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Chimerism Blood Transfusion Wounds and Injuries |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Prospective Study of the Kinetics and Mechanisms of Transfusion-Associated Microchimerism in Injured Patients |
Whole blood, plasma, peripheral blood mononuclear cells
Estimated Enrollment: | 360 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2011 |
Approximately 20% of individuals who suffer a traumatic injury require a blood transfusion; of these, 10% to 15% experience a condition known as transfusion-associated microchimerism. This occurs when white blood cells, or leukocytes, from the donor's blood persist in the recipient long after the transfusion occurs. The genetically distinct donor cells can remain in the individual for decades, and may account for as many as 4% of the white blood cells in the recipient's body. This suggests that the donor cells are tolerated by the recipient's immune system. The purpose of this study is to examine the specific factors that predispose some blood transfusion recipients to develop microchimerism.
In this study, blood samples will be collected from injured individuals who arrive at the University of California at Davis Medical Center. Individuals who receive a blood transfusion, as well as a control group of individuals who do not receive a transfusion, will be approached to enroll in the study.
Individuals who agree to participate will have their blood collected at Days 7, 14, and 28 and Months 3 and 6. Study researchers will analyze the blood for evidence of microchimerism. Participants with microchimerism will undergo additional blood collection at Months 12, 18, 24, 30, and 36. Information will be collected from all participants on health status, injury characteristics, hospital care, blood transfusion details, and blood donor characteristics.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Emergency Department
Inclusion Criteria:
Exclusion Criteria:
Contact: Garth H. Utter, MD, MSc | 916-734-1768 | garth.utter@ucdmc.ucdavis.edu |
United States, California | |
University of California, Davis, Medical Center | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: Garth H. Utter, MD, MSc 916-734-1768 garth.utter@ucdmc.ucdavis.edu | |
Contact: Ryan M. Rivers, BS 916-734-3204 ryan.rivers@ucdmc.ucdavis.edu |
Principal Investigator: | Michael P. Busch, MD, PhD | Blood Systems Research Institute |
Responsible Party: | Blood Systems Research Institute ( Michael Busch ) |
Study ID Numbers: | 1362, 1 R01 HL083388-01A1-1 |
Study First Received: | November 15, 2006 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00400192 History of Changes |
Health Authority: | United States: Federal Government |
Microchimerism Injuries Leukocytes Immunologic Techniques |
Wounds and Injuries Disorders of Environmental Origin |
Wounds and Injuries Disorders of Environmental Origin |