Detailed Evaluation of Microchimerism

April 11, 2013 updated by: Blood Systems Research Institute

Evaluation to Determine Whether Transfusion-associated Microchimerism Involves Engraftment With Hematopoietic Progenitor Cells

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.

Study Overview

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis, Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Previous study participants

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael P. Busch, MD, PhD, Blood Systems Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

March 25, 2010

First Submitted That Met QC Criteria

March 25, 2010

First Posted (Estimate)

March 26, 2010

Study Record Updates

Last Update Posted (Estimate)

April 12, 2013

Last Update Submitted That Met QC Criteria

April 11, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 695
  • 1R01HL083388 (U.S. NIH Grant/Contract)
  • R01HL083388 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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