Red Cell Storage Duration and Outcomes in Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Red Cell Storage Duration and Outcomes in Cardiac Surgery

Conditions
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Blood Transfusion, Cardiac Surgery

Intervention / Treatment
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* Biological: Prolonged RBC storage
* Biological: Short RBC storage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prolonged RBC storage<br>Transfusion with oldest available matching RBCs. | Biological: Prolonged RBC storage<br>* Transfusion with oldest available matching RBCs<br>|
| Active Comparator: Short RBC storage<br>Transfusion with youngest available matching RBCs. | Biological: Short RBC storage<br>* Transfusion with youngest available matching RBCs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 30 days post surgery. | 
| 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. | 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. | 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. | 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. | 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. | 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. | 30 days post surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | The total days from start to end of the Hospital Stay. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transfusion, Cardiac, Blood storage duration