NCT01094197

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

April 12, 2013

Status Verified

April 1, 2013

Enrollment Period

1.7 years

First QC Date

March 25, 2010

Last Update Submit

April 11, 2013

Conditions

Keywords

Transfusion-associated microchimerismInjuriesLeukocytes

Study Arms (1)

Transfused microchimeric subject

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Previous study participants

You may qualify if:

  • Demonstrated long-term microchimerism following transfusion for traumatic injury

You may not qualify if:

  • Prior bone marrow or solid organ transplantation
  • Pregnancy
  • Blood transfusion within the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis, Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (4)

  • 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.

    PMID: 15514522BACKGROUND
  • 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.

    PMID: 16078913BACKGROUND
  • 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.

    PMID: 17845255BACKGROUND
  • 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.

    PMID: 18503616BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Leukapheresis filtrate and/or whole blood samples

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Michael P. Busch, MD, PhD

    Vitalant Research Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 26, 2010

Study Start

March 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

April 12, 2013

Record last verified: 2013-04

Locations