Immunomodulation Following Transfusion

Completed · Phase 4

Conditions studied: Blood Component Transfusion

In brief

This study is designed to provide information on patients' immune response after exposure to transfused blood. Blood transfusions may have opposite immune effects on patients. One is sensitization. The other is immunosuppression. The magnitude of these effects in patients who are not on chemotherapy is unknown. These effects are thought to be due largely to white blood cells present in the transfusion product. "Leukofiltration" and "gamma-irradiation" are the special treatments that deplete white blood cells. A combination of leukofiltration and gamma-irradiation pretreatment of donor blood is thought to deplete the white blood cells most effectively. In this study, patients scheduled for cardiac surgery are randomly assigned to receive blood products pretreated in one of three ways: untreated, filtered or filtered and irradiated. If their physician orders transfusions, they will receive products assigned to their group. Patients are asked to provide two blood samples during the 4 weeks after surgery. Studies will measure changes in antibody to HLA and in cells that regulate the immune response. The levels of sensitization and immunosuppression will be correlated to the transfusion products received.

Key facts

Study ID

NCT00810810

Run by

University of Washington

People needed

287

Starts

2006-07-01

Expected to finish

2011-08-01

Last updated by the study team

2017-12-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 year of age
• Scheduled for open heart surgery of cardiopulmonary bypass that involves: CABG, CABG with valve, aneurysm repair
• Urgent or elective surgery

You may not qualify if…

• Scheduled for open heart surgery of cardiopulmonary bypass that involves: placement of a ventricular assist device, cardiac transplantation, aortic dissection repair
• Emergent surgery
• participation in other clinical research studies within 30 days of randomization.
• Immunosuppressive treatment.
• Refuse blood transfusion
• Disease or condition placing subject at undue risk or decision of attending doctor.
• Condition requiring high volume transfusion therapy

Where it is running

• Northwest Hospital — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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