Transfusion-Associated Microchimerism in Individuals Receiving a Blood Transfusion After a Traumatic Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400192
Recruitment Status : Completed
First Posted : November 16, 2006
Last Update Posted : April 15, 2013
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Blood Systems Research Institute

Brief Summary:
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 or disease
Chimerism Blood Transfusion Wounds and Injuries

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.

Study Type : Observational
Actual Enrollment : 451 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of the Kinetics and Mechanisms of Transfusion-associated Microchimerism in Injured Patients
Study Start Date : November 2006
Actual Primary Completion Date : August 2010
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Prevalence and magnitude of transfusion-associated microchimerism [ Time Frame: 1, 2 and 4 weeks, 3 and 6 months ]

Biospecimen Retention:   Samples With DNA
Whole blood, plasma, peripheral blood mononuclear cells

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Emergency Department

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400192

United States, California
University of California, Davis, Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
Blood Systems Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Michael P. Busch, MD, PhD Blood Systems Research Institute