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

July 11, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Retrospective Study of the Prevalence of Transfusion-Associated Microchimerism Following Traumatic Injury, Burns, and Elective Orthopedic Procedures

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

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

United States
- 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

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Previously hospitalized patients

Description

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

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: Cohort
Time Perspectives: Retrospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Traumatic injury
2 Elective orthopedic surgery
3 Burn injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Microchimerism Time Frame: 5-11 years after transfusion	5-11 years after transfusion

Collaborators and Investigators

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

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

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.

General Publications

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

August 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

February 28, 2007

First Submitted That Met QC Criteria