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
  Purpose

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.


Condition Intervention Phase
Wounds and Injuries
Procedure: Leukoreduced blood transfusion
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Leukoreduction in Infection Risk in Trauma

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Infection within 30 days of injury [ Time Frame: 30 d ]

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 300
Study Start Date: February 2003
Study Completion Date: September 2004
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135291

Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98004
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Avery B Nathens, MD PhD MPH University of Washington
  More Information

Publications:
Responsible Party: Avery B Nathens, MD PhD MPH
ClinicalTrials.gov Identifier: NCT00135291     History of Changes
Other Study ID Numbers: 02-2517-D02, P50 HL073996-01
Study First Received: August 23, 2005
Last Updated: January 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
transfusion-induced immunomodulation
leukoreduction
surgical site infections
nosocomial infections
transfusion
Infection
Sepsis
Hemorrhage

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014