Detailed Evaluation of Microchimerism

NCT ID: NCT01094197

Last Updated: 2013-04-12

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-11-30

Brief Summary

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Individuals who experience traumatic injury often require blood transfusion. In some individuals who receive blood after an injury, white blood cells from a person who donated blood may remain in the body for years, a condition known as microchimerism. This study is designed to examine a group of people who are known to have long-term microchimerism and, through analysis of their blood, determine whether there is evidence that the microchimerism involves blood stem cells that can become any type of blood cell (red blood cells, white blood cells, or platelets) and that might be a permanent part of the body.

Detailed Description

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Transfusion-associated microchimerism, the persistence of donor white blood cells months or years after transfusion in the recipient, has been observed in approximately 10-15% of transfused trauma patients. Previous studies suggest that the microchimeric cells include multiple immunophenotypes of leukocytes (CD4+, CD8+, CD15+, and CD19+) and that they can persist for decades, features suggestive of hematopoietic engraftment.

In this study, ten subjects known to have long-term microchimerism will undergo either leukapheresis (a blood filtering procedure) or collection of a 500 mL whole blood sample (the amount of a standard blood donation). These samples will then be analyzed to determine whether the microchimeric (donor) cells include hematopoietic stem cells (CD34+) and precursor cells in the red blood cell, white blood cell, and platelet lineages.

Conditions

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Chimerism Blood Transfusion Wounds and Injuries Hematopoiesis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Transfused microchimeric subject

Former trauma patient who underwent blood transfusion and has recent evidence of long-term transfusion-associated microchimerism

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Demonstrated long-term microchimerism following transfusion for traumatic injury

Exclusion Criteria

* Prior bone marrow or solid organ transplantation
* Pregnancy
* Blood transfusion within the past 12 months
Minimum Eligible Age

18 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)

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)

Utter GH, Reed WF, Lee TH, Busch MP. Transfusion-associated microchimerism. Vox Sang. 2007 Oct;93(3):188-95. doi: 10.1111/j.1423-0410.2007.00954.x.

Reference Type BACKGROUND
PMID: 17845255 (View on PubMed)

Utter GH, Lee TH, Rivers RM, Montalvo L, Wen L, Chafets DM, Reed WF, Busch MP. Microchimerism decades after transfusion among combat-injured US veterans from the Vietnam, Korean, and World War II conflicts. Transfusion. 2008 Aug;48(8):1609-15. doi: 10.1111/j.1537-2995.2008.01758.x. Epub 2008 May 22.

Reference Type BACKGROUND
PMID: 18503616 (View on PubMed)

Other Identifiers

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R01HL083388

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01HL083388

Identifier Type: NIH

Identifier Source: secondary_id

View Link

695

Identifier Type: -

Identifier Source: org_study_id

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