Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications

Mayo Clinic

Status and phase: Completed; Phase 2; Phase 1

Conditions: Blood Transfusion Complications

Treatments: Biological: Standard of care red blood cell transfusion.; Biological: Point-of-care washed red blood cell transfusion.

Study type: Interventional

Funder types: Other

Identifiers

NCT02094118

13-005965

Details and patient eligibility

About

This study is designed to determine if point-of-care washing of allogeneic Leukocyte-Reduced Red Blood Cells reduces pulmonary complications when compared to standard-of-care Leukocyte-Reduced Red Blood Cells in a cardiac surgical population.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age equal to or greater than 18 years of age.
• Scheduled to have cardiac bypass surgery at Mayo Clinic in Rochester, Minnesota or Duke University Medical Center in Durham, North Carolina
• At risk for needing at least 4 units of blood during/after surgery

Exclusion criteria

• Emergency surgery
• Immunoglobulin A (IgA) deficiency
• History of severe recurrent transfusion reactions
• Refusal to receive allogeneic blood products
• Refusal to provide informed consent
• Prevalent lung injury prior to randomization
• Prevalent congestive heart failure prior to randomization
• Expected hospital stay < 48 hours
• Not anticipated to survive > 48 hours
• Previously enrolled in this trial
• No plan for placement of a pulmonary artery catheter
• Use of home oxygen therapy
• Complex RBC antibody profiles
• Need for the use of irradiated RBCs

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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171 participants in 2 patient groups

Standard of care red blood cell transfusion

Active Comparator group

Description:

Red blood cells that are administered in the normal fashion.

Treatment:

Biological: Standard of care red blood cell transfusion.

Point-of-Care washed red blood cell transfusion

Experimental group

Description:

Red blood cells that are washed at the point-of-care.

Treatment:

Biological: Point-of-care washed red blood cell transfusion.