Blood Transfusion, Cardiac Surgery
Conditions
Keywords
Transfusion, Cardiac, Blood storage duration
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.
Interventions
BIOLOGICALProlonged RBC storage
Transfusion with oldest available matching RBCs
BIOLOGICALShort RBC storage
Transfusion with youngest available matching RBCs
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of RBC Age on Occurrence of Vascular Events | 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 Gastrointestinal Events | 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 Any Reoperation | 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. |
| Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery. | 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 Mortality or Multisystem Organ Failure Events | 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 Neurologic Events | 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. |
| Effect of RBC Age on Occurrence of Pulmonary Events. | 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 Renal Failure | 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 | 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 | 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 Asystole | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of RBC Age on Postoperative Hospital Lengths of Stay. | The total days from start to end of the Hospital 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. |
| 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). | 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. |
Countries
United States
Participant flow
Pre-assignment details
From July 2007 to May 2016, 3942 adults undergoing coronary artery bypass grafting, cardiac valve procedures, or ascending aorta repair, either alone or in combination were enrolled in the study. 3835 adults were randomized to transfusion of RBCs stored for ≤ 14 days (younger units) or for ≥ 20 days (older units) intraoperatively and throughout the postoperative hospitalization
Participants by arm
| Arm | Count |
|---|---|
| Prolonged RBC Storage Transfusion with oldest available matching RBCs.
Prolonged RBC storage: Transfusion with oldest available matching RBCs | 686 |
| Short RBC Storage Transfusion with youngest available matching RBCs.
Short RBC storage: Transfusion with youngest available matching RBCs | 701 |
| Total | 1,387 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1,228 | 1,220 |
Baseline characteristics
| Characteristic | Prolonged RBC Storage | Short RBC Storage | Total |
|---|---|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 12 | 69 years STANDARD_DEVIATION 12 | 69 years STANDARD_DEVIATION 12 |
| Body mass index | 28 kg/m2 STANDARD_DEVIATION 5.9 | 28 kg/m2 STANDARD_DEVIATION 5.9 | 28 kg/m2 STANDARD_DEVIATION 5.9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 326 Participants | 381 Participants | 707 Participants |
| Sex: Female, Male Male | 360 Participants | 320 Participants | 680 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 23 / 686 | 15 / 701 |
| other Total, other adverse events | 0 / 686 | 0 / 701 |
| serious Total, serious adverse events | 360 / 686 | 362 / 701 |
Outcome results
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged RBC Storage | Effect of RBC Age on Occurrence of Any Reoperation | 81 Participants |
| Short RBC Storage | Effect of RBC Age on Occurrence of Any Reoperation | 69 Participants |
95% CI: [0.5, 1.3]
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged RBC Storage | Effect of RBC Age on Occurrence of Asystole | 29 Participants |
| Short RBC Storage | Effect of RBC Age on Occurrence of Asystole | 13 Participants |
95% CI: [0.16, 1.1]
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged RBC Storage | Effect of RBC Age on Occurrence of Atrial Fibrillation | 238 Participants |
| Short RBC Storage | Effect of RBC Age on Occurrence of Atrial Fibrillation | 258 Participants |
95% CI: [0.8, 1.5]
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged RBC Storage | Effect of RBC Age on Occurrence of Gastrointestinal Events | 33 Participants |
| Short RBC Storage | Effect of RBC Age on Occurrence of Gastrointestinal Events | 28 Participants |
95% CI: [0.39, 1.7]
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged RBC Storage | Effect of RBC Age on Occurrence of Infection Events | 12 Participants |
| Short RBC Storage | Effect of RBC Age on Occurrence of Infection Events | 10 Participants |
95% CI: [0.24, 2.8]
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged RBC Storage | Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events | 24 Participants |
| Short RBC Storage | Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events | 16 Participants |
95% CI: [0.25, 1.6]
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged RBC Storage | Effect of RBC Age on Occurrence of Neurologic Events | 19 Participants |
| Short RBC Storage | Effect of RBC Age on Occurrence of Neurologic Events | 14 Participants |
95% CI: [0.26, 2]
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged RBC Storage | Effect of RBC Age on Occurrence of Pulmonary Events. | 113 Participants |
| Short RBC Storage | Effect of RBC Age on Occurrence of Pulmonary Events. | 106 Participants |
95% CI: [0.59, 1.4]
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged RBC Storage | Effect of RBC Age on Occurrence of Renal Failure | 36 Participants |
| Short RBC Storage | Effect of RBC Age on Occurrence of Renal Failure | 32 Participants |
95% CI: [0.43, 1.8]
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged RBC Storage | Effect of RBC Age on Occurrence of Vascular Events | 9 Participants |
| Short RBC Storage | Effect of RBC Age on Occurrence of Vascular Events | 7 Participants |
95% CI: [0.18, 3.2]
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prolonged RBC Storage | Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery. | 360 Participants |
| Short RBC Storage | Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery. | 362 Participants |
p-value: 0.0895% CI: [0.5, 1.2]generalized estimating equation (GEE)
Secondary
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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prolonged RBC Storage | Effect of RBC Age on Intensive Care Unit (ICU) Length of Stay. | 54 Hours |
| Short RBC Storage | Effect of RBC Age on Intensive Care Unit (ICU) Length of Stay. | 51 Hours |
p-value: 0.995% CI: [0.94, 1.29]Regression, Cox
Secondary
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prolonged RBC Storage | Effect of RBC Age on Postoperative Hospital Lengths of Stay. | 9 Days |
| Short RBC Storage | Effect of RBC Age on Postoperative Hospital Lengths of Stay. | 9 Days |
p-value: 0.0795% CI: [0.85, 1.18]Regression, Cox