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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
3,942
Transfusion with oldest available matching RBCs
Transfusion with youngest available matching RBCs
Cleveland Clinic
Cleveland, Ohio, United States
Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery.
The primary composite endpoint was the occurrence of mortality or multisystem organ failure, cardiac events (ventricular tachycardia, fibrillation, or asystole; atrial fibrillation), pulmonary events (pneumonia, prolonged postoperative ventilation, pulmonary embolus), neurologic events (stroke, coma), renal failure, infection (deep sternal wound infection, sepsis), gastrointestinal events (ischemia, infarction), any reoperation (for bleeding, tamponade, cardiac dysfunction), and vascular events (dissection, limb ischemia), as defined for the STS database.
Time frame: 30 days post surgery.
Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Mortality or Multisystem Organ Failure events in Patients Undergoing Cardiac Surgery.
Time frame: 30 days post surgery
Effect of RBC Age on Occurrence of Neurologic Events
Neurologic events includes stroke and coma. Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Mortality or Neurologic events in Patients Undergoing Cardiac Surgery.
Time frame: 30 days post surgery.
Effect of RBC Age on Occurrence of Pulmonary Events.
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Pulmonary events in Patients Undergoing Cardiac Surgery. Pulmonary events include pneumonia, prolonged postoperative ventilation and pulmonary embolus.
Time frame: 30 days post surgery.
Effect of RBC Age on Occurrence of Renal Failure
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Renal Failure in Patients Undergoing Cardiac Surgery.
Time frame: 30 days post surgery.
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Effect of RBC Age on Occurrence of Infection Events
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Infection events in Patients Undergoing Cardiac Surgery. Infection events include deep sternal wound infection and sepsis.
Time frame: 30 days post surgery.
Effect of RBC Age on Occurrence of Atrial Fibrillation
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Atrial fibrillation in Patients Undergoing Cardiac Surgery.
Time frame: 30 days post surgery.
Effect of RBC Age on Occurrence of Asystole
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Asystole in Patients Undergoing Cardiac Surgery.
Time frame: 30 days post surgery.
Effect of RBC Age on Occurrence of Gastrointestinal Events
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Gastrointestinal events in Patients Undergoing Cardiac Surgery. Gastrointestinal events include ischemia and infarction.
Time frame: 30 days post surgery.
Effect of RBC Age on Occurrence of Any Reoperation
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to any Postoperative Reoperation in Patients Undergoing Cardiac Surgery. Reoperation for bleeding, tamponade and cardiac dysfunction.
Time frame: 30 days post surgery.
Effect of RBC Age on Occurrence of Vascular Events
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Vascular events in Patients Undergoing Cardiac Surgery. Vascular events include dissection and limb ischemia.
Time frame: 30 days post surgery.
Effect of RBC Age on Intensive Care Unit (ICU) Length of Stay.
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Intensive Care Unit (ICU) Length of Stay in Patients Undergoing Cardiac Surgery.
Time frame: The total hours from start to end in the Intensive Care Unit (ICU).
Effect of RBC Age on Postoperative Hospital Lengths of Stay.
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Hospital Lengths of Stay in Patients Undergoing Cardiac Surgery.
Time frame: The total days from start to end of the Hospital Stay.