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OpenTrials
Completed

NCT Number: NCT00400192

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

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Davis, Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence and magnitude of transfusion-associated microchimerism

    Time frame: 1, 2 and 4 weeks, 3 and 6 months

Sponsors and collaborators

Lead sponsor

Vitalant Research Institute

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Prospective Study of the Kinetics and Mechanisms of Transfusion-associated Microchimerism in Injured Patients

Important dates

Study start
2006
Primary completion
2010
Study completion
2012
First posted
Nov 16, 2006
Registry last updated
Apr 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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