Wounds and InjuriesPhase 2/3NCT00135291
Effect of Leukoreduced Blood Transfusions on Infection Following Trauma
A Phase 2/3 study testing Leukoreduced blood transfusion in people with Wounds and Injuries, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to determine if leukoreduced blood transfusions reduce the risk of infection following trauma. Specifically, the investigators intend to evaluate whether there are clinically relevant differences in the rates of infection and in the severity of multiple organ failure in critically injured… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Leukoreduced blood transfusion
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Sep 2004
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Trauma patients
- Age > 17
- Transfusion within 24 hours of injury
Who cannot join
- Active infection at time of injury
- Anticipated survival of < 48 hours (e.g. gunshot wound [GSW] to head, cardiopulmonary resuscitation [CPR] in progress)
- Receipt of blood products for this injury event prior to randomization
- AB negative; B negative blood type.
- Positive antibody screen
- Prior requirement for irradiated, leukoreduced or cytomegalovirus (CMV) seronegative blood products
- Incarcerated
- Enrolled in pre-hospital trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98004
About this study
Official title: Effect of Leukoreduction in Infection Risk in Trauma
The purpose of this study is to determine if leukoreduced blood transfusions reduce the risk of infection following trauma. Specifically, the investigators intend to evaluate whether there are clinically relevant differences in the rates of infection and in the severity of multiple organ failure in critically injured trauma patients receiving leukoreduced blood products compared to those receiving standard allogeneic blood products.
Read the detailed description
Many severely injured patients survive their initial resuscitation only to suffer the late sequelae of nosocomial infection and multiple organ failure. The depth of hemorrhagic shock and the severity of anatomic injury are clearly associated with these adverse outcomes, however there is clear evidence to suggest that events during the resuscitation phase also play an important role in the pathogenesis of these sequelae. Specifically, there is now substantial clinical and experimental evidence implicating blood transfusion and the transfusion of allogeneic passenger leukocytes in the immune dysregulation characteristic of the post-injury state. This immune dysregulation manifests on two fronts: an uncontrolled inflammatory response leading to organ dysfunction and a state of immunoparalysis, leading to the development of nosocomial infection. Allogeneic passenger leukocytes have been implicated in the alterations in non-specific and specific immunity that underlie this state of altered immunoresponsiveness. The importance of allogeneic leukocytes in these phenomena suggests that strategies designed to limit the exposure of patients to these cells may reduce the incidence of post-injury sequelae. Pre-storage leukoreduction, whereby donated blood is passed through a leukocyte filter prior to storage and ultimate transfusion is one such strategy. This strategy remains at the center of a national debate on a policy of universal leukoreduction in which its efficacy is unproven and its cost undisputed.
Study Objectives:
- To evaluate whether there are clinically relevant differences in the rates of infection and in the severity of multiple organ failure in critically injured trauma patients receiving leukoreduced blood products compared to those receiving standard allogeneic blood products.
- To assess T-cell responsiveness and the dominant CD4 lymphocyte subset as measured by T-lymphocyte IL-2 receptor expression and cytokine profile, respectively, in critically injured subjects transfused with leukoreduced blood products compared to subjects receiving standard allogeneic blood products.
- To assess the activational state of the peripheral blood monocyte and the neutrophil in critically injured trauma patients receiving leukoreduced blood products compared to subjects receiving standard allogeneic blood products.
- To evaluate whether there are clinically relevant differences in rates of acute lung injury (ALI) and circulating markers of ALI in patients receiving leukoreduced versus standard allogeneic blood products.
- To evaluate rates of microchimerism in those receiving leukoreduced versus standard allogeneic transfusion
- Conditions
- Wounds and Injuries
- Being tested
- Leukoreduced blood transfusion
- Keywords
- transfusion-induced immunomodulation, leukoreduction, surgical site infections, nosocomial infections, transfusion, Infection, Sepsis, Hemorrhage
- Medical subject headings
- Wounds and Injuries, Surgical Wound Infection, Cross Infection, Infections, Sepsis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukoreduced blood transfusionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection within 30 days of injury
Measured: 30 d
Secondary outcomes (9)
Marshall organ dysfunction scores over the course of Intensive Care Unit (ICU) admission
Hospital length of stay
Duration of mechanical ventilation
Duration of ICU stay
Acute lung injury
Plasma circulating levels of inflammatory cytokines and markers of lung injury (days 2-3 and 6-8)
Measures of monocyte activation (days 2-3 and 6-8)
Measures of polymorphonuclear neutrophil (PMN) activation (days 2-3 and 6-8)
Peripheral blood mononuclear cell expression of interleukin-2 (IL-2) receptors (days 2-3 and 6-8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startFeb 2003
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Avery B Nathens, MD PhD MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135291
- Sponsor's protocol ID
- 02-2517-D02
- Other IDs
- P50HL073996-01
- Status last verified
- Jan 2008
- First submitted
- 23 Aug 2005
- Last updated
- 11 Jan 2008
- Results posted
- No
Publications
Nathens AB, Nester TA, Rubenfeld GD, Nirula R, Gernsheimer TB. The effects of leukoreduced blood transfusion on infection risk following injury: a randomized controlled trial. Shock. 2006 Oct;26(4):342-7. doi: 10.1097/01.shk.0000228171.32587.a1.
PubMed 16980879Utter GH, Nathens AB, Lee TH, Reed WF, Owings JT, Nester TA, Busch MP. Leukoreduction of blood transfusions does not diminish transfusion-associated microchimerism in trauma patients. Transfusion. 2006 Nov;46(11):1863-9. doi: 10.1111/j.1537-2995.2006.00991.x.
PubMed 17076839
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Leukoreduction in Infection Risk in Trauma
- ClinicalTrials.gov ID
- NCT00135291
- Acronym / sponsor ID
- 02-2517-D02
- Conditions
- Wounds and Injuries
- Keywords
- transfusion-induced immunomodulation, leukoreduction, surgical site infections, nosocomial infections, transfusion, Infection, Sepsis, Hemorrhage
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Feb 2003
- Study completion
- Sep 2004 (actual)
- First posted
- 25 Aug 2005 (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.
The purpose of this study is to determine if leukoreduced blood transfusions reduce the risk of infection following trauma. Specifically, the investigators intend to evaluate whether there are clinically relevant differences in the rates of infection and in the severity of multiple organ failure in critically injured trauma patients receiving leukoreduced blood products compared to those receiving standard allogeneic blood products.
Detailed description
Many severely injured patients survive their initial resuscitation only to suffer the late sequelae of nosocomial infection and multiple organ failure. The depth of hemorrhagic shock and the severity of anatomic injury are clearly associated with these adverse outcomes, however there is clear evidence to suggest that events during the resuscitation phase also play an important role in the pathogenesis of these sequelae. Specifically, there is now substantial clinical and experimental evidence implicating blood transfusion and the transfusion of allogeneic passenger leukocytes in the immune dysregulation characteristic of the post-injury state. This immune dysregulation manifests on two fronts: an uncontrolled inflammatory response leading to organ dysfunction and a state of immunoparalysis, leading to the development of nosocomial infection. Allogeneic passenger leukocytes have been implicated in the alterations in non-specific and specific immunity that underlie this state of altered immunoresponsiveness. The importance of allogeneic leukocytes in these phenomena suggests that strategies designed to limit the exposure of patients to these cells may reduce the incidence of post-injury sequelae. Pre-storage leukoreduction, whereby donated blood is passed through a leukocyte filter prior to storage and ultimate transfusion is one such strategy. This strategy remains at the center of a national debate on a policy of universal leukoreduction in which its efficacy is unproven and its cost undisputed.
Study Objectives:
- To evaluate whether there are clinically relevant differences in the rates of infection and in the severity of multiple organ failure in critically injured trauma patients receiving leukoreduced blood products compared to those receiving standard allogeneic blood products.
- To assess T-cell responsiveness and the dominant CD4 lymphocyte subset as measured by T-lymphocyte IL-2 receptor expression and cytokine profile, respectively, in critically injured subjects transfused with leukoreduced blood products compared to subjects receiving standard allogeneic blood products.
- To assess the activational state of the peripheral blood monocyte and the neutrophil in critically injured trauma patients receiving leukoreduced blood products compared to subjects receiving standard allogeneic blood products.
- To evaluate whether there are clinically relevant differences in rates of acute lung injury (ALI) and circulating markers of ALI in patients receiving leukoreduced versus standard allogeneic blood products.
- To evaluate rates of microchimerism in those receiving leukoreduced versus standard allogeneic transfusion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Trauma patients
- Age > 17
- Transfusion within 24 hours of injury
Key exclusion criteria (8 listed)
- Active infection at time of injury
- Anticipated survival of < 48 hours (e.g. gunshot wound [GSW] to head, cardiopulmonary resuscitation [CPR] in progress)
- Receipt of blood products for this injury event prior to randomization
- AB negative; B negative blood type.
- Positive antibody screen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leukoreduced blood transfusion | Procedure or surgery | – |
Primary outcome
Infection within 30 days of injury
Time frame: 30 d
9 secondary outcomes
Marshall organ dysfunction scores over the course of Intensive Care Unit (ICU) admission
Hospital length of stay
Duration of mechanical ventilation
Duration of ICU stay
Acute lung injury
Plasma circulating levels of inflammatory cytokines and markers of lung injury (days 2-3 and 6-8)
Measures of monocyte activation (days 2-3 and 6-8)
Measures of polymorphonuclear neutrophil (PMN) activation (days 2-3 and 6-8)
Peripheral blood mononuclear cell expression of interleukin-2 (IL-2) receptors (days 2-3 and 6-8)
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 11 Jan 2008.
- Results publication: PubMed 16980879Nathens AB, Nester TA, Rubenfeld GD, Nirula R, Gernsheimer TB. The effects of leukoreduced blood transfusion on infection risk following injury: a randomized controlled trial. Shock. 2006 Oct;26(4):342-7. doi: 10.1097/01.shk.0000228171.32587.a1.
- Results publication: PubMed 17076839Utter GH, Nathens AB, Lee TH, Reed WF, Owings JT, Nester TA, Busch MP. Leukoreduction of blood transfusions does not diminish transfusion-associated microchimerism in trauma patients. Transfusion. 2006 Nov;46(11):1863-9. doi: 10.1111/j.1537-2995.2006.00991.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.
Avery B Nathens, MD PhD MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Leukoreduced blood transfusion in people with Wounds and Injuries, run by University of Washington 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 3 inclusion and 8 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 11 Jan 2008. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Infection within 30 days of injury (time frame: 30 d). 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 NCT00135291, which also lists 2 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 11 Jan 2008.