Detailed Evaluation of Microchimerism

This study has been withdrawn prior to enrollment.

(Investigators could not identify subjects who met all inclusion criteria.)

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

Blood Systems Research Institute

ClinicalTrials.gov Identifier:

NCT01094197

First received: March 25, 2010

Last updated: April 11, 2013

Last verified: April 2013

History of Changes

Purpose

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.

Condition
Chimerism Blood Transfusion Wounds and Injuries Hematopoiesis

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Cross-Sectional
Official Title:	Evaluation to Determine Whether Transfusion-associated Microchimerism Involves Engraftment With Hematopoietic Progenitor Cells

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Injuries Wounds

U.S. FDA Resources

Further study details as provided by Blood Systems Research Institute:

Biospecimen Retention: Samples With DNA

Leukapheresis filtrate and/or whole blood samples

Enrollment:	0
Study Start Date:	March 2010
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Transfused microchimeric subject Former trauma patient who underwent blood transfusion and has recent evidence of long-term transfusion-associated microchimerism

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Previous study participants

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094197

Locations

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)

Investigators

Principal Investigator:

Michael P. Busch, MD, PhD

Blood Systems Research Institute

More Information

Publications:

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.

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.

Utter GH, Reed WF, Lee TH, Busch MP. Transfusion-associated microchimerism. Vox Sang. 2007 Oct;93(3):188-95. Review.

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. Epub 2008 May 22.

Responsible Party:	Blood Systems Research Institute
ClinicalTrials.gov Identifier:	NCT01094197 History of Changes
Other Study ID Numbers:	695, R01HL083388, 1R01HL083388
Study First Received:	March 25, 2010
Last Updated:	April 11, 2013
Health Authority:	United States: Federal Government

Keywords provided by Blood Systems Research Institute:

Transfusion-associated microchimerism
Injuries
Leukocytes

Additional relevant MeSH terms:

Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013

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