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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00441779
First received: February 28, 2007
Last updated: March 4, 2010
Last verified: March 2010
  Purpose

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.


Condition
Chimerism
Blood Transfusion
Wounds and Injuries

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study of the Prevalence of Transfusion-Associated Microchimerism Following Traumatic Injury, Burns, and Elective Orthopedic Procedures

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Biospecimen Retention:   Samples With DNA

Whole blood, plasma, peripheral blood mononuclear cells


Estimated Enrollment: 600
Study Start Date: August 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Traumatic injury
2
Elective orthopedic surgery
3
Burn injury

Detailed Description:

Approximately 10% to 15% of injured patients who receive blood transfusions experience a condition known as transfusion-associated microchimerism. This occurs when white blood cells, or leukocytes, from the donor's blood persist in the recipient long after the transfusion occurs. The genetically distinct donor cells can remain in the individual for decades, and may account for as many as 4% of the white blood cells in the recipient's body. This suggests that the donor cells are tolerated by the recipient's immune system. The purpose of this study is to compare the incidence of microchimerism among individuals with three different types of injuries: 1) traumatic injuries; 2) thermal, or burn, injuries; and 3) injuries resulting from elective orthopedic surgical procedures.

In this study, blood samples will be collected from individuals who were treated for traumatic injury, thermal injury, or elective orthopedic surgical procedures at the University of California at Davis Medical Center. Individuals who were treated from 2000 to 2003 and received a blood transfusion, as well as a control group of individuals who did not receive a transfusion, will be approached to enroll in the study. Individuals who agree to participate will have their blood analyzed for evidence of microchimerism. Information on health status, injury characteristics, hospital care, blood transfusion details, and blood donor characteristics will be collected from all participants.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Previously hospitalized patients

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441779

Locations
United States, California
University of California, Davis, Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
Investigators
Principal Investigator: Michael P. Busch, MD, PhD Blood Systems Research Institute
  More Information

Publications:
Responsible Party: Michael Busch, Blood Systems Research Institute
ClinicalTrials.gov Identifier: NCT00441779     History of Changes
Other Study ID Numbers: 1378, 1 R01 HL083388-01A1-2
Study First Received: February 28, 2007
Last Updated: March 4, 2010
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Microchimerism
Injuries
Burns
Orthopedic Surgery
Leukocytes

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on September 14, 2014