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

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

Genetics Home Reference related topics:

aceruloplasminemia

MedlinePlus related topics:

Blood Transfusion and Donation Edema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study

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

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 ]

Estimated Enrollment:	100
Study Start Date:	August 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator RBC transfusion of conventional storage age	Other: RBC transfusion of conventional storage age RBC transfusion of conventional storage age

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

Responsible Party:	Mayo Clinic ( Ognjen Gajic, M.D. )
Study ID Numbers:	07-008069, P50 HL081027
First Received:	September 9, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00751322
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Pulmonary

Protein

Study placed in the following topic categories:

Pulmonary Edema

Respiratory Tract Diseases

Hematologic Diseases

Blood Protein Disorders

Lung Diseases

Edema

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00751322