Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135291
Status:
COMPLETED
Last Update Posted:
2008-01-11
First Post:
2005-08-23
Brief Title:
Effect of Leukoreduced Blood Transfusions on Infection Following Trauma
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Effect of Leukoreduction in Infection Risk in Trauma
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50HL073996-01 | NIH | None | httpsreporternihgovquickSearchP50HL073996-01 |