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The primary purpose of this study is to determine the best blood level to begin transfusing red blood cells in individuals undergoing cardiac surgery.
The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery.
Consecutive consenting patients who meet the inclusion criteria will be randomized to one of 2 transfusion groups based on their HCT value.
Hematocrit Groups:
Red blood cell transfusion will be given only when hematocrit values fall below the assigned group value. When the hematocrit value falls to a value less than the value for the randomized group a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to the randomized group no further transfusions will be administered. A measurement of the patient's HCT after each unit of RBC administered is required prior to administering additional units. If a patient's hematocrit is greater than the value for the group which they are randomized, no transfusion of RBC is necessary. Other management decisions are left up to the discretion of the care team. Adherence to the treatment protocol will be required for the patients in the operating room, intensive care unit and postoperatively until discharge from the hospital.
Before surgery, the patient will be asked to respond to a quality-of-life questionnaire. Follow up phone calls will be made by Study personnel at 1 and 3 months after surgery to ask the same questions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood transfusion triggers of 24% hematocrit value | Active Comparator | Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered. |
|
| Blood transfusion triggers of 28% hematocrit value | Active Comparator | Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood transfusion at hematocrit value less than 24% | Procedure | transfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| A Composite of In-hospital Postoperative Morbidity and Mortality | The composite components were in-hospital mortality, neurologic morbidity (stroke or coma), pulmonary morbidity (pneumonia, pulmonary embolus, or prolonged postoperative ventilation [>24 hours]), renal morbidity (renal failure), infectious morbidity (deep sternal wound infection, septicemia, or sepsis), cardiac arrhythmia (atrial fibrillation, ventricular tachycardia, fibrillation, or asystole), gastrointestinal morbidity, reoperation (for bleeding, tamponade, graft occlusion, valve dysfunction, or noncardiac reasons), and vascular morbidity (aortic or femoral artery dissection or acute limb ischemia). | After surgery until hosptal discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Length of ICU Stays | After surgery until discharged from ICU | |
| Length of Hospital Stay | After surgery until hospital discharge | |
| Number of Blood Transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel I Sessler, MD | The Cleveland Clinic | Study Chair |
| Daniel I Sessler, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States | ||
| S.A.L. Hospital and Medical Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41114449 | Derived | Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6. | |
| 34932836 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Blood Transfusion Triggers of 24% Hematocrit Value | Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered. |
| FG001 | Blood Transfusion Triggers of 28% Hematocrit Value | Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Blood Transfusion Triggers of 24% Hematocrit Value | Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered. |
| 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 | A Composite of In-hospital Postoperative Morbidity and Mortality | The composite components were in-hospital mortality, neurologic morbidity (stroke or coma), pulmonary morbidity (pneumonia, pulmonary embolus, or prolonged postoperative ventilation [>24 hours]), renal morbidity (renal failure), infectious morbidity (deep sternal wound infection, septicemia, or sepsis), cardiac arrhythmia (atrial fibrillation, ventricular tachycardia, fibrillation, or asystole), gastrointestinal morbidity, reoperation (for bleeding, tamponade, graft occlusion, valve dysfunction, or noncardiac reasons), and vascular morbidity (aortic or femoral artery dissection or acute limb ischemia). | Posted | Count of Participants | Participants | After surgery until hosptal discharge |
|
After surgery until hospital discharge or 30 days which comes first
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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 | Blood Transfusion Triggers of 24% Hematocrit Value | Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Sessler, MD | Cleveland Clinic Foundation | 216-4444900 | ds@or.org |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Blood transfusion at hematocrit value less than 28% | Procedure | transfusion |
|
| From induction to the end of sugery |
| Prolonged Postoperative Ventilation | On ventilation >24 hours after surgery | After surgeyr until hospital discharge |
| Postoperative Atrial Fibrillation | After surgery until hospital discharge |
| Ahmedabad |
| Thaltej, |
| 380054 |
| India |
| Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5. |
| BG001 | Blood Transfusion Triggers of 28% Hematocrit Value | Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered. |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| Hematocrit | Median | Inter-Quartile Range | volume percentage of red blood cells |
|
| Serum creatinine | Median | Inter-Quartile Range | mg/dL |
|
| OG001 | Blood Transfusion Triggers of 28% Hematocrit Value | Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered. |
|
|
| Secondary | Length of ICU Stays | Posted | Median | Inter-Quartile Range | hours | After surgery until discharged from ICU |
|
|
|
| Secondary | Length of Hospital Stay | Posted | Median | Inter-Quartile Range | days | After surgery until hospital discharge |
|
|
|
| Secondary | Number of Blood Transfusion | Posted | Median | Inter-Quartile Range | times | From induction to the end of sugery |
|
|
|
| Secondary | Prolonged Postoperative Ventilation | On ventilation >24 hours after surgery | Posted | Count of Participants | Participants | After surgeyr until hospital discharge |
|
|
|
| Secondary | Postoperative Atrial Fibrillation | Posted | Count of Participants | Participants | After surgery until hospital discharge |
|
|
|
| 0 |
| 363 |
| 0 |
| 363 |
| 0 |
| 363 |
| EG001 | Blood Transfusion Triggers of 28% Hematocrit Value | Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered. | 0 | 354 | 0 | 354 | 0 | 354 |
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