Transfusion-Associated Microchimerism in Previously Injured Individuals Who Received a Blood Transfusion

NCT00441779 | Terminated

• 2 other identifiers: 13781R01HL083388
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Blood transfusions are frequently necessary in situations in which there is a large amount of blood loss. 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 evaluate the occurrence of microchimerism among the following three groups of individuals who previously received transfusions: 1) individuals with traumatic injuries; 2) individuals with burn injuries; and 3) individuals who underwent elective orthopedic operations.

Conditions

Chimerism; Blood Transfusion; Wounds and Injuries

Keywords

Microchimerism; Injuries; Burns; Orthopedic Surgery; Leukocytes

Outcome Measures

Primary Outcomes (1)

• Microchimerism

  5-11 years after transfusion

Study Arms (3)

1

Traumatic injury

2

Elective orthopedic surgery

3

Burn injury

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Previously hospitalized patients

You may qualify if:

• Hospitalized for traumatic injury, thermal injury, or an elective orthopedic surgical procedure from 2000 to 2003 at the University of California at Davis Medical Center
• Received at least 1 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
• Prior blood transfusion other than at the time of hospitalization
• Any history of an autoimmune disorder prior to hospitalization

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

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: 15514522 BACKGROUND

• 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: 15920405 BACKGROUND

• 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: 16078913 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, peripheral blood mononuclear cells

MeSH Terms

Conditions

Wounds and Injuries; Burns

Study Officials

• Michael P. Busch, MD, PhD

  Vitalant Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 1, 2007
• Study Start: August 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 12, 2016

Record last verified: 2014-10

Locations

US (1)