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Transfusion-Associated Microchimerism in Individuals Receiving a Blood Transfusion After a Traumatic Injury
This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), April 2009
First Received: November 15, 2006   Last Updated: April 7, 2009   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00400192
  Purpose

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
Chimerism
Blood Transfusion
Wounds and Injuries

MedlinePlus related topics: Blood Transfusion and Donation Injuries Wounds
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Prospective Study of the Kinetics and Mechanisms of Transfusion-Associated Microchimerism in Injured Patients

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Whole blood, plasma, peripheral blood mononuclear cells


Estimated Enrollment: 360
Study Start Date: November 2006
Estimated Study Completion Date: November 2011
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Emergency Department

Criteria

Inclusion Criteria:

  • Hospitalized for a traumatic injury
  • Received at least one unit of transfused red blood cells

Exclusion Criteria:

  • Currently incarcerated
  • Inadequate decision-making capacity of the participant and no available surrogate decision-maker
  • Prior bone marrow or solid organ transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400192

Contacts
Contact: Garth H. Utter, MD, MSc 916-734-1768 garth.utter@ucdmc.ucdavis.edu

Locations
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    
Sponsors and Collaborators
Investigators
Principal Investigator: Michael P. Busch, MD, PhD Blood Systems Research Institute
  More Information

Publications:
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

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Microchimerism
Injuries
Leukocytes
Immunologic Techniques

Study placed in the following topic categories:
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 06, 2009