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

Not Applicable

Completed

• Conditions: Pulmonary Edemas; Blood Protein Disorders
• Interventions: Other: RBC transfusion of conventional storage age; Other: RBC transfusion of 5 days or less storage age

• Registration Number: NCT00751322
• Lead Sponsor: Mayo Clinic

Brief 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).

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-09
• Study First Submitted QC: 2008-09-10
• Study First Posted: 2008-09-11
• Primary Completion: 2010-07
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-27
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	RBC transfusion of conventional storage age	RBC transfusion of conventional storage age
1	RBC transfusion of 5 days or less storage age	RBC transfusion of 5 days or less storage age

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States