Transfusion-Induced Alterations of Pulmonary and Immune Function in Mechanically Ventilated Patients

Blood Protein Disorders Clinical Trial

— TRALI2  

Official title:

Project 2 (Mayo): Transfusion-Induced Alterations of Pulmonary and Immune Function in Mechanically Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751322
• Other study ID #: 07-008069
• Secondary ID: P50HL081027
• Status: Completed
• Phase: N/A
• First received: September 9, 2008
• Last updated: January 27, 2012
• Start date: August 2008
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Specific aim: To test whether transfusion of leukoreduced red cells of lesser storage time (versus conventional storage time) reduces mild alterations in pulmonary function and immune activation in critically ill patients with mechanically ventilated lungs.

We propose to perform a prospective, randomized, double-blind clinical trial in critically ill patients whose lungs are mechanically ventilated, and who have orders to receive transfusion of at least one unit of packed red cells, comparing pulmonary function between patients randomly allocated to receive a unit of red cells stored for 5 days or less, with similar patients randomly allocated to receive a unit of red cells stored conventionally (median 21 days). We will test the hypothesis that transfusion of red cells of lesser storage age, (5 days or less) will produce the less changes of pulmonary function and immune activation than will transfusion of red cells of conventional storage age (median 21 days).

Description:

Specific aim: To test whether transfusion of leukoreduced red cells of lesser storage time (versus conventional storage time) reduces mild alterations in pulmonary function and immune activation in critically ill patients with mechanically ventilated lungs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients, male or female, any race or ethnicity, age 18 years or older, in one of the seven adult critical care units of the Mayo Clinic, Rochester, with mechanically ventilated lungs, requiring elective transfusion of at least one unit of red cells

Exclusion Criteria:

• transfusion of any blood component within the previous 2 hours, emergency transfusion or hemodynamic instability defined by other than a stable dose of vasoactive medications.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Blood Protein Disorders
• Pulmonary Edema
• Pulmonary Edemas

Intervention

Other:
• RBC transfusion of 5 days or less storage age
RBC transfusion of 5 days or less storage age
• RBC transfusion of conventional storage age
RBC transfusion of conventional storage age

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We will test the hypothesis that the transfusion of red cells of lesser storage age, (5 days or less) will produce less changes of pulmonary function and immune activation than will transfusion of red cells of conventional storage age (median 21 days).		At the end of the transfusion as compared to the beginning of the transfusion	No