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

NCT ID: NCT00400192

Last Updated: 2013-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

451 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chimerism Blood Transfusion Wounds and Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Vitalant Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael P. Busch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vitalant Research Institute

Locations

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University of California, Davis, Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

References

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Utter GH, Owings JT, Lee TH, Paglieroni TG, Reed WF, Gosselin RC, Holland PV, Busch MP. Blood transfusion is associated with donor leukocyte microchimerism in trauma patients. J Trauma. 2004 Oct;57(4):702-7; discussion 707-8. doi: 10.1097/01.ta.0000140666.15972.37.

Reference Type BACKGROUND
PMID: 15514522 (View on PubMed)

Utter GH, Owings JT, Lee TH, Paglieroni TG, Reed WF, Gosselin RC, Holland PV, Busch MP. Microchimerism in transfused trauma patients is associated with diminished donor-specific lymphocyte response. J Trauma. 2005 May;58(5):925-31; discussion 931-2. doi: 10.1097/01.ta.0000162142.72817.5c.

Reference Type BACKGROUND
PMID: 15920405 (View on PubMed)

Lee TH, Paglieroni T, Utter GH, Chafets D, Gosselin RC, Reed W, Owings JT, Holland PV, Busch MP. High-level long-term white blood cell microchimerism after transfusion of leukoreduced blood components to patients resuscitated after severe traumatic injury. Transfusion. 2005 Aug;45(8):1280-90. doi: 10.1111/j.1537-2995.2005.00201.x.

Reference Type BACKGROUND
PMID: 16078913 (View on PubMed)

Other Identifiers

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R01HL083388

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1362

Identifier Type: -

Identifier Source: org_study_id

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