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

Primary Purpose

Pulmonary Edemas, Blood Protein Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RBC transfusion of 5 days or less storage age
RBC transfusion of conventional storage age
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Edemas focused on measuring Pulmonary, Protein

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

RBC transfusion of 5 days or less storage age

RBC transfusion of conventional storage age

Outcomes

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).

Secondary Outcome Measures

Full Information

First Posted
September 9, 2008
Last Updated
January 27, 2012
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00751322
Brief Title
Transfusion-Induced Alterations of Pulmonary and Immune Function in Mechanically Ventilated Patients
Acronym
TRALI2
Official Title
Project 2 (Mayo): Transfusion-Induced Alterations of Pulmonary and Immune Function in Mechanically Ventilated Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Edemas, Blood Protein Disorders
Keywords
Pulmonary, Protein

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
RBC transfusion of 5 days or less storage age
Arm Title
2
Arm Type
Active Comparator
Arm Description
RBC transfusion of conventional storage age
Intervention Type
Other
Intervention Name(s)
RBC transfusion of 5 days or less storage age
Other Intervention Name(s)
RBC
Intervention Description
RBC transfusion of 5 days or less storage age
Intervention Type
Other
Intervention Name(s)
RBC transfusion of conventional storage age
Other Intervention Name(s)
RBC
Intervention Description
RBC transfusion of conventional storage age
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ognjen Gajic, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22281833
Citation
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.
Results Reference
derived

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

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