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Transfusion-Induced Alterations of Pulmonary and Immune Function in Mechanically Ventilated Patients (TRALI2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ognjen Gajic, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00751322
First received: September 9, 2008
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

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).


Condition Intervention
Pulmonary Edemas
Blood Protein Disorders
 Other: RBC transfusion of 5 days or less storage age
Other: RBC transfusion of conventional storage age

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Project 2 (Mayo): Transfusion-Induced Alterations of Pulmonary and Immune Function in Mechanically Ventilated Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: August 2008
Study Completion Date: December 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
RBC transfusion of 5 days or less storage age
 Other: RBC transfusion of 5 days or less storage age
RBC transfusion of 5 days or less storage age
Other Name: RBC
Active Comparator: 2
RBC transfusion of conventional storage age
 Other: RBC transfusion of conventional storage age
RBC transfusion of conventional storage age
Other Name: RBC

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751322

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Ognjen Gajic, M.D. Mayo Clinic
  More Information

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ognjen Gajic, Ognjen Gajic, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00751322     History of Changes
Other Study ID Numbers: 07-008069, P50 HL081027
Study First Received: September 9, 2008
Last Updated: January 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Pulmonary
Protein

Additional relevant MeSH terms:
Blood Protein Disorders
Edema
Pulmonary Edema
Hematologic Diseases
 Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013