Red Cell Storage Duration and Outcomes in Cardiac Surgery

NeuroTherapia, Inc.

Status: Completed

Conditions: Cardiac Surgery; Blood Transfusion

Treatments: Biological: Short RBC storage; Biological: Prolonged RBC storage

Study type: Interventional

Funder types: Other

Identifiers

NCT00458783

07-140

Details and patient eligibility

About

The purpose of this study is to determine whether length of storage of RBC is related to postoperative morbid outcomes in patients undergoing cardiac surgery.

Full description

Subjects undergoing cardiac surgery will be randomized into one of two groups. Group A will receive transfused blood that has storage duration less than 14 days. Group B will receive transfused blood with a storage duration of more than 20 days.

Enrollment: 3,942 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All primary and reoperative adult cardiac surgical patients undergoing cardiopulmonary bypass for coronary artery bypass grafting, coronary artery bypass grafting with a valve procedure, isolated valve procedures, ascending aortic aneurysm or dissection repair alone or combined with CABG and valve procedures

Exclusion criteria

• Age less than 18 years
• Descending thoracic aortic aneurysm repairs
• Left or right ventricular assist devices
• Those unable to receive blood for religious reasons

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,942 participants in 2 patient groups

Prolonged RBC storage

Active Comparator group

Description:

Transfusion with oldest available matching RBCs.

Treatment:

Biological: Prolonged RBC storage

Short RBC storage

Active Comparator group

Description:

Transfusion with youngest available matching RBCs.

Treatment:

Biological: Short RBC storage