ChimerismNCT00400192
Transfusion-Associated Microchimerism in Individuals Receiving a Blood Transfusion After a Traumatic Injury
An observational study of Chimerism and Blood Transfusion, run by Vitalant Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Chimerism, Blood Transfusion, Wounds and Injuries
- How many people
- 451 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Emergency Department
Who may be able to join
- Hospitalized for a traumatic injury
- Received at least one unit of transfused red blood cells
Who cannot join
- Currently incarcerated
- Inadequate decision-making capacity of the participant and no available surrogate decision-maker
- Prior bone marrow or solid organ transplantation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis, Medical Center
Sacramento, California, 95817
About this study
Official title: Prospective Study of the Kinetics and Mechanisms of Transfusion-associated Microchimerism in Injured Patients
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.
Read the detailed description
Approximately 20% of individuals who suffer a traumatic injury require a blood transfusion; of these, 10% to 15% 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 examine the specific factors that predispose some blood transfusion recipients to develop microchimerism.
In this study, blood samples will be collected from injured individuals who arrive at the University of California at Davis Medical Center. Individuals who receive a blood transfusion, as well as a control group of individuals who do not receive a transfusion, will be approached to enroll in the study. Individuals who agree to participate will have their blood collected at Days 7, 14, and 28 and Months 3 and 6. Study researchers will analyze the blood for evidence of microchimerism. Participants with microchimerism will undergo additional blood collection at Months 12, 18, 24, 30, and 36. Information will be collected from all participants on health status, injury characteristics, hospital care, blood transfusion details, and blood donor characteristics.
- Conditions
- Chimerism, Blood Transfusion, Wounds and Injuries
- Keywords
- Microchimerism, Injuries, Leukocytes, Immunologic Techniques
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and magnitude of transfusion-associated microchimerism
Measured: 1, 2 and 4 weeks, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionAug 2010
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ChimerismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitalant Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michael P. Busch, MD, PhD, Principal investigator, Vitalant Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400192
- Sponsor's protocol ID
- 1362
- Other IDs
- R01HL083388
- Status last verified
- Apr 2013
- First submitted
- 15 Nov 2006
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15514522Utter 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.
PubMed 15920405Lee 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.
PubMed 16078913
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Kinetics and Mechanisms of Transfusion-associated Microchimerism in Injured Patients
- ClinicalTrials.gov ID
- NCT00400192
- Acronym / sponsor ID
- 1362
- Conditions
- Chimerism, Blood Transfusion, Wounds and Injuries
- Keywords
- Microchimerism, Injuries, Leukocytes, Immunologic Techniques
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Vitalant Research InstituteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 20% of individuals who suffer a traumatic injury require a blood transfusion; of these, 10% to 15% 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 examine the specific factors that predispose some blood transfusion recipients to develop microchimerism.
In this study, blood samples will be collected from injured individuals who arrive at the University of California at Davis Medical Center. Individuals who receive a blood transfusion, as well as a control group of individuals who do not receive a transfusion, will be approached to enroll in the study. Individuals who agree to participate will have their blood collected at Days 7, 14, and 28 and Months 3 and 6. Study researchers will analyze the blood for evidence of microchimerism. Participants with microchimerism will undergo additional blood collection at Months 12, 18, 24, 30, and 36. Information will be collected from all participants on health status, injury characteristics, hospital care, blood transfusion details, and blood donor characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Emergency Department
Key inclusion criteria (2 listed)
- Hospitalized for a traumatic injury
- Received at least one unit of transfused red blood cells
Key exclusion criteria (3 listed)
- Currently incarcerated
- Inadequate decision-making capacity of the participant and no available surrogate decision-maker
- Prior bone marrow or solid organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and magnitude of transfusion-associated microchimerism
Time frame: 1, 2 and 4 weeks, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
- Background: PubMed 15514522Utter 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.
- Background: PubMed 15920405Utter 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.
- Background: PubMed 16078913Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P. Busch, MD, PhD principal investigator
Vitalant Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chimerism and Blood Transfusion, run by Vitalant Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and magnitude of transfusion-associated microchimerism (time frame: 1, 2 and 4 weeks, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00400192, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2013.