Red Cell Storage Duration and Outcomes in Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 3,942
- Locations
- 1
- Primary Endpoint
- Effect of RBC Age on Occurrence of Renal Failure
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Prolonged RBC storage
Transfusion with oldest available matching RBCs.
Intervention: Prolonged RBC storage (Biological)
Short RBC storage
Transfusion with youngest available matching RBCs.
Intervention: Short RBC storage (Biological)
Outcomes
Primary Outcomes
Effect of RBC Age on Occurrence of Renal Failure
Time Frame: 30 days post surgery.
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Renal Failure in Patients Undergoing Cardiac Surgery.
Effect of RBC Age on Occurrence of Infection Events
Time Frame: 30 days post surgery.
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.
Effect of RBC Age on Occurrence of Atrial Fibrillation
Time Frame: 30 days post surgery.
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Atrial fibrillation in Patients Undergoing Cardiac Surgery.
Effect of RBC Age on Occurrence of Any Reoperation
Time Frame: 30 days post surgery.
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.
Effect of RBC Age on Occurrence of Gastrointestinal Events
Time Frame: 30 days post surgery.
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.
Effect of RBC Age on Occurrence of Vascular Events
Time Frame: 30 days post surgery.
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.
Effect of RBC Age on Occurrence of Pulmonary Events.
Time Frame: 30 days post surgery.
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.
Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events
Time Frame: 30 days post surgery
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.
Effect of RBC Age on Occurrence of Asystole
Time Frame: 30 days post surgery.
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Asystole in Patients Undergoing Cardiac Surgery.
Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery.
Time Frame: 30 days post 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.
Effect of RBC Age on Occurrence of Neurologic Events
Time Frame: 30 days post surgery.
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.
Secondary Outcomes
- Effect of RBC Age on Postoperative Hospital Lengths of Stay.(The total days from start to end of the Hospital Stay.)
- Effect of RBC Age on Intensive Care Unit (ICU) Length of Stay.(The total hours from start to end in the Intensive Care Unit (ICU).)