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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged RBC storage | Active Comparator | Transfusion with oldest available matching RBCs. |
|
| Short RBC storage | Active Comparator | Transfusion with youngest available matching RBCs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged RBC storage | Biological | Transfusion with oldest available matching RBCs |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andra Duncan, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23874777 | Derived | Kekre N, Mallick R, Allan D, Tinmouth A, Tay J. The impact of prolonged storage of red blood cells on cancer survival. PLoS One. 2013 Jul 16;8(7):e68820. doi: 10.1371/journal.pone.0068820. Print 2013. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Prolonged RBC Storage | Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs |
| FG001 | Short RBC Storage | Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prolonged RBC Storage | Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs |
| BG001 | Short RBC Storage | Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 30 days post surgery. |
|
30 days post surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prolonged RBC Storage | Transfusion with oldest available matching RBCs. Prolonged RBC storage: Transfusion with oldest available matching RBCs |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multisystem organ failure | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andra Duncan, MD | Cleveland Clinic | 216-445-2372 | duncana@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2010 | Apr 27, 2021 | Prot_SAP_000.pdf |
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| Short RBC storage | Biological | Transfusion with youngest available matching RBCs |
|
| 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. |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| OG001 | Short RBC Storage | Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs |
|
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| 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. | Posted | Count of Participants | Participants | 30 days post surgery |
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| 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. | Posted | Count of Participants | Participants | 30 days post surgery. |
|
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|
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| 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. | Posted | Count of Participants | Participants | 30 days post surgery. |
|
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|
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| 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. | Posted | Count of Participants | Participants | 30 days post surgery. |
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| 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. | Posted | Count of Participants | Participants | 30 days post surgery. |
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| 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. | Posted | Count of Participants | Participants | 30 days post surgery. |
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| 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. | Posted | Count of Participants | Participants | 30 days post surgery. |
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| 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. | Posted | Count of Participants | Participants | 30 days post surgery. |
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| 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. | Posted | Count of Participants | Participants | 30 days post surgery. |
|
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| 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. | Posted | Count of Participants | Participants | 30 days post surgery. |
|
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| 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. | Posted | Median | Inter-Quartile Range | Hours | The total hours from start to end in the Intensive Care Unit (ICU). |
|
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| 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. | Posted | Median | Inter-Quartile Range | Days | The total days from start to end of the Hospital Stay. |
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| 23 |
| 686 |
| 360 |
| 686 |
| 0 |
| 686 |
| EG001 | Short RBC Storage | Transfusion with youngest available matching RBCs. Short RBC storage: Transfusion with youngest available matching RBCs | 15 | 701 | 362 | 701 | 0 | 701 |
| Stroke | Nervous system disorders | Non-systematic Assessment |
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| Coma | Nervous system disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Prolonged ventilation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Renal morbidity | Renal and urinary disorders | Non-systematic Assessment |
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| Deep sternal wound infection | Infections and infestations | Non-systematic Assessment |
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| Septicemia/sepsis | Immune system disorders | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Asystole | Cardiac disorders | Non-systematic Assessment |
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| Gastrointestinal morbidity | Gastrointestinal disorders | Non-systematic Assessment |
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| Bleeding/tamponade | Surgical and medical procedures | Non-systematic Assessment |
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| Graft occlusion/valve dysfunction, noncardiac reasons | Surgical and medical procedures | Non-systematic Assessment |
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| Aortic or femoral artery dissection | Vascular disorders | Non-systematic Assessment |
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| Acute limb ischemia | Vascular disorders | Non-systematic Assessment |
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