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| ID | Type | Description | Link |
|---|---|---|---|
| P50HL073996-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leukoreduced blood transfusion | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Infection within 30 days of injury | 30 d |
| Measure | Description | Time Frame |
|---|---|---|
| Marshall organ dysfunction scores over the course of Intensive Care Unit (ICU) admission | ||
| Hospital length of stay | ||
| Duration of mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avery B Nathens, MD PhD MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Seattle | Washington | 98004 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16980879 | Result | 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. | |
| 17076839 | Result | Utter 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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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D013530 | Surgical Wound Infection |
| D003428 | Cross Infection |
| D007239 | Infections |
| D018805 | Sepsis |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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) |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |