Effect of Leukoreduced Blood Transfusions on Infection Following Trauma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00135291
First received: August 23, 2005
Last updated: January 2, 2008
Last verified: January 2008

August 23, 2005
January 2, 2008
February 2003
Not Provided
Infection within 30 days of injury [ Time Frame: 30 d ]
Infection within 30 days of injury
Complete list of historical versions of study NCT00135291 on ClinicalTrials.gov Archive Site
  • 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)
  • Marshall organ dysfunction scores over the course of 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 PMN activation (days 2-3 and 6-8)
  • Peripheral blood mononuclear cell expression of IL-2 receptors (days 2-3 and 6-8)
Not Provided
Not Provided
 
Effect of Leukoreduced Blood Transfusions on Infection Following Trauma
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.

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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Wounds and Injuries
Procedure: Leukoreduced blood transfusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
September 2004
Not Provided

Inclusion Criteria:

  • Trauma patients
  • Age > 17
  • Transfusion within 24 hours of injury

Exclusion Criteria:

  • 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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00135291
02-2517-D02, P50 HL073996-01
Not Provided
Avery B Nathens, MD PhD MPH
University of Washington
National Institutes of Health (NIH)
Principal Investigator: Avery B Nathens, MD PhD MPH University of Washington
University of Washington
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP