## Protocol Section
### Identification Module
**NCT ID:** NCT00441779

**Brief Title:** Transfusion-Associated Microchimerism in Previously Injured Individuals Who Received a Blood Transfusion

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

#### Organization Study ID Info
**ID:** 1378
#### Organization
**Class:** NIH
**Full Name:** National Heart, Lung, and Blood Institute (NHLBI)
#### Secondary ID Infos
**ID:** 1R01HL083388
**Link:** https://reporter.nih.gov/quickSearch/1R01HL083388
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2011-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-07-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-07-11

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2011-10

**Type:** ACTUAL

#### Start Date
**Date:** 2008-08

**Status Verified Date:** 2014-10

#### Study First Post Date
**Date:** 2007-03-01
**Type:** ESTIMATED
**Study First Submit Date:** 2007-02-28
**Study First Submit QC Date:** 2007-02-28
**Why Stopped:** A separate study (similar subjects) identified transfusion-associated microchimerism only rarely, making this observational study impractical to conduct.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NIH

**Name:** National Heart, Lung, and Blood Institute (NHLBI)

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Chimerism

- Blood Transfusion

- Wounds and Injuries

**Keywords:**

- Microchimerism

- Injuries

- Burns

- Orthopedic Surgery

- Leukocytes

### Design Module

#### Bio Spec

**Description:** Whole blood, plasma, peripheral blood mononuclear cells

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 59

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Traumatic injury

**Label:** 1

#### Arm Group 2

**Description:** Elective orthopedic surgery

**Label:** 2

#### Arm Group 3

**Description:** Burn injury

**Label:** 3

### Outcomes Module

#### Primary Outcomes

**Measure:** Microchimerism

**Time Frame:** 5-11 years after transfusion

### Eligibility Module

**Eligibility 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

**Minimum Age:** 8 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Previously hospitalized patients

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sacramento

**Country:** United States

**Facility:** University of California, Davis, Medical Center

**State:** California

**Zip:** 95817

#### Overall Officials

**Official 1:**

**Affiliation:** Vitalant Research Institute

**Name:** Michael P. Busch, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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

**Citation:** 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

**Citation:** 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

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Wounds and Injuries

- ID: M5326

- Name: Burns

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014947

- Term: Wounds and Injuries

### Misc Info Module

- Version Holder: 2024-05-24
