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

NCT00751322 | Completed

• 2 other identifiers: 07-008069P50HL081027
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Edemas; Blood Protein Disorders

Keywords

Pulmonary; Protein

Outcome Measures

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).

  At the end of the transfusion as compared to the beginning of the transfusion

Study Arms (2)

1

ACTIVE COMPARATOR

RBC transfusion of 5 days or less storage age

Other: 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

Interventions

RBC transfusion of 5 days or less storage age OTHER

RBC transfusion of 5 days or less storage age

Also known as: RBC

1

RBC transfusion of conventional storage age OTHER

RBC transfusion of conventional storage age

Also known as: RBC

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 22281833 DERIVED

MeSH Terms

Conditions

Pulmonary Edema; Blood Protein Disorders

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Ognjen Gajic, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ognjen Gajic, M.D.

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 11, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2011
• Last Updated: January 31, 2012

Record last verified: 2012-01

Locations

US (1)