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CompletedNCT00751322TRALI2Updated Jan 31, 2012

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

An interventional study of RBC transfusion of 5 days or less storage age and RBC transfusion of conventional storage age in Pulmonary Edemas and Blood Protein Disorders, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-31.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Pulmonary Edemas
  • Blood Protein Disorders

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Keywords

  • Pulmonary
  • Protein
03

In context

Pulmonary Edema

138 studies on the registry are indexed under Pulmonary Edema; 24 are open to participants now.

This study's enrollment of 100 is above the median of 68 across 72 interventional studies indexed under Pulmonary Edema.

Browse Pulmonary Edema studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    1

    RBC transfusion of 5 days or less storage age

    Other: RBC transfusion of 5 days or less storage age

  • Active comparator
    2

    RBC transfusion of conventional storage age

    Other: RBC transfusion of conventional storage age

Interventions

  • OtherRBC transfusion of 5 days or less storage age

    RBC transfusion of 5 days or less storage age

    Also known as: RBC

  • OtherRBC transfusion of conventional storage age

    RBC transfusion of conventional storage age

    Also known as: RBC

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What researchers measure

Primary outcomes

  1. 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

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Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
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References and documents

Publications

  • Kor DJ, Kashyap R, Weiskopf RB, Wilson GA, van Buskirk CM, Winters JL, Malinchoc M, Hubmayr RD, Gajic O. Fresh red blood cell transfusion and short-term pulmonary, immunologic, and coagulation status: a randomized clinical trial. Am J Respir Crit Care Med. 2012 Apr 15;185(8):842-50. doi: 10.1164/rccm.201107-1332OC. Epub 2012 Jan 26. PubMed 22281833 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00751322
Lead sponsor
Mayo Clinic
Responsible party
Ognjen Gajic (Ognjen Gajic, M.D., Mayo Clinic) — Principal investigator
First posted
Sep 11, 2008
Start date
Aug 2008
Primary completion
Jul 2010
Completion
Dec 2011
Last update
Jan 31, 2012

Study contacts

Ognjen Gajic, M.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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