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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulmonary Edemas, Blood Protein Disorders

Intervention / Treatment
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* Other: RBC transfusion of 5 days or less storage age
* Other: RBC transfusion of conventional storage age


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>RBC transfusion of 5 days or less storage age | Other: RBC transfusion of 5 days or less storage age<br>* RBC transfusion of 5 days or less storage age<br>* Other names: RBC;|
| Active Comparator: 2<br>RBC transfusion of conventional storage age | Other: RBC transfusion of conventional storage age<br>* RBC transfusion of conventional storage age<br>* Other names: RBC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protein, Pulmonary