NCT00400192

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
451

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 15, 2013

Status Verified

April 1, 2013

Enrollment Period

3.8 years

First QC Date

November 15, 2006

Last Update Submit

April 11, 2013

Conditions

Keywords

MicrochimerismInjuriesLeukocytesImmunologic Techniques

Outcome Measures

Primary Outcomes (1)

  • Prevalence and magnitude of transfusion-associated microchimerism

    1, 2 and 4 weeks, 3 and 6 months

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Emergency Department

You may qualify if:

  • Hospitalized for a traumatic injury
  • Received at least one unit of transfused red blood cells

You may not qualify if:

  • Currently incarcerated
  • Inadequate decision-making capacity of the participant and no available surrogate decision-maker
  • Prior bone marrow or solid organ transplantation

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 (3)

  • 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
  • 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.

    PMID: 15920405BACKGROUND
  • 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

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, peripheral blood mononuclear cells

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Michael P. Busch, MD, PhD

    Vitalant Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 16, 2006

Study Start

November 1, 2006

Primary Completion

August 1, 2010

Study Completion

July 1, 2012

Last Updated

April 15, 2013

Record last verified: 2013-04

Locations