Effect of Leukoreduced Blood Transfusions on Infection Following Trauma

NCT00135291 | Completed Phase 2

• 2 other identifiers: 02-2517-D02P50HL073996-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds and Injuries

Keywords

transfusion-induced immunomodulation; leukoreduction; surgical site infections; nosocomial infections; transfusion; Infection; Sepsis; Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Infection within 30 days of injury

  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

Interventions

Leukoreduced blood transfusion PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98004, United States

Location

Related Publications (2)

• 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.

  PMID: 16980879 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.

  PMID: 17076839 RESULT

MeSH Terms

Conditions

Wounds and Injuries; Surgical Wound Infection; Cross Infection; Infections; Sepsis; Hemorrhage

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Iatrogenic Disease; Disease Attributes; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Avery B Nathens, MD PhD MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 23, 2005
• First Posted: August 25, 2005
• Study Start: February 1, 2003
• Study Completion: September 1, 2004
• Last Updated: January 11, 2008

Record last verified: 2008-01

Locations

US (1)