- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00751322
Transfusion-Induced Alterations of Pulmonary and Immune Function in Mechanically Ventilated Patients (TRALI2)
Project 2 (Mayo): Transfusion-Induced Alterations of Pulmonary and Immune Function in Mechanically Ventilated Patients
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
RBC transfusion of 5 days or less storage age
|
RBC transfusion of 5 days or less storage age
Other Names:
|
Active Comparator: 2
RBC transfusion of conventional storage age
|
RBC transfusion of conventional storage age
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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).
Time Frame: At the end of the transfusion as compared to the beginning of the transfusion
|
At the end of the transfusion as compared to the beginning of the transfusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ognjen Gajic, M.D., Mayo Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-008069
- P50HL081027 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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