Transfusion-Associated Microchimerism in Previously Injured Individuals Who Received a Blood Transfusion

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: NCT00441779
Recruitment Status : Terminated (A separate study (similar subjects) identified transfusion-associated microchimerism only rarely, making this observational study impractical to conduct.)
First Posted : March 1, 2007
Last Update Posted : July 12, 2016
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
Blood transfusions are frequently necessary in situations in which there is a large amount of blood loss. 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 evaluate the occurrence of microchimerism among the following three groups of individuals who previously received transfusions: 1) individuals with traumatic injuries; 2) individuals with burn injuries; and 3) individuals who underwent elective orthopedic operations.

Condition or disease
Chimerism Blood Transfusion Wounds and Injuries

Detailed Description:

Approximately 10% to 15% of injured patients who receive blood transfusions 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 compare the incidence of microchimerism among individuals with three different types of injuries: 1) traumatic injuries; 2) thermal, or burn, injuries; and 3) injuries resulting from elective orthopedic surgical procedures.

In this study, blood samples will be collected from individuals who were treated for traumatic injury, thermal injury, or elective orthopedic surgical procedures at the University of California at Davis Medical Center. Individuals who were treated from 2000 to 2003 and received a blood transfusion, as well as a control group of individuals who did not receive a transfusion, will be approached to enroll in the study. Individuals who agree to participate will have their blood analyzed for evidence of microchimerism. Information on health status, injury characteristics, hospital care, blood transfusion details, and blood donor characteristics will be collected from all participants.

Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study of the Prevalence of Transfusion-Associated Microchimerism Following Traumatic Injury, Burns, and Elective Orthopedic Procedures
Study Start Date : August 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Traumatic injury
Elective orthopedic surgery
Burn injury

Primary Outcome Measures :
  1. Microchimerism [ Time Frame: 5-11 years after transfusion ]

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:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Previously hospitalized patients

Inclusion Criteria:

  • Hospitalized for traumatic injury, thermal injury, or an elective orthopedic surgical procedure from 2000 to 2003 at the University of California at Davis Medical Center
  • Received at least 1 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
  • Prior blood transfusion other than at the time of hospitalization
  • Any history of an autoimmune disorder prior to hospitalization

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): NCT00441779

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