Anemia
Conditions
Keywords
Surgery, Cardiopulmonary bypass, Coronary artery bypass graft, Valve procedure, Hematocrit level, Outcomes
Brief summary
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.
Detailed description
Consecutive consenting patients who meet the inclusion criteria will be randomized to one of 2 transfusion groups based on their HCT value. Hematocrit Groups: 1. 24% 2. 28% 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.
Interventions
PROCEDUREBlood transfusion at hematocrit value less than 24%
transfusion
PROCEDUREBlood transfusion at hematocrit value less than 28%
transfusion
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 and ascending aortic repair for aneurysm or dissection procedures.
Exclusion criteria
* Age less than 18 years * Congenital procedures * Emergencies * descending thoracic aortic aneurysm repairs * Left or right ventricular assist devices * Left ventricular aneurysm resections * Heart or lung transplantation * Those unable to receive blood for religious reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A Composite of In-hospital Postoperative Morbidity and Mortality | After surgery until hosptal discharge | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU Stays | After surgery until discharged from ICU | — |
| Length of Hospital Stay | After surgery until hospital discharge | — |
| Number of Blood Transfusion | From induction to the end of sugery | — |
| Prolonged Postoperative Ventilation | After surgeyr until hospital discharge | On ventilation \>24 hours after surgery |
| Postoperative Atrial Fibrillation | After surgery until hospital discharge | — |
Countries
India, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 363 |
| 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. | 354 |
| Total | 717 |
Baseline characteristics
| Characteristic | Blood Transfusion Triggers of 24% Hematocrit Value | Total | Blood Transfusion Triggers of 28% Hematocrit Value |
|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 15 | 60 years STANDARD_DEVIATION 14 | 60 years STANDARD_DEVIATION 13 |
| Hematocrit | 37.1 volume percentage of red blood cells | 37.6 volume percentage of red blood cells | 38.0 volume percentage of red blood cells |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment India | 240 participants | 482 participants | 242 participants |
| Region of Enrollment United States | 123 participants | 235 participants | 112 participants |
| Serum creatinine | 0.87 mg/dL | 0.87 mg/dL | 0.87 mg/dL |
| Sex: Female, Male Female | 133 Participants | 254 Participants | 121 Participants |
| Sex: Female, Male Male | 230 Participants | 463 Participants | 233 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 363 | 0 / 354 |
| other Total, other adverse events | 0 / 363 | 0 / 354 |
| serious Total, serious adverse events | 0 / 363 | 0 / 354 |
Outcome results
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).
Time frame: After surgery until hosptal discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blood Transfusion Triggers of 24% Hematocrit Value | A Composite of In-hospital Postoperative Morbidity and Mortality | 59 Participants |
| Blood Transfusion Triggers of 28% Hematocrit Value | A Composite of In-hospital Postoperative Morbidity and Mortality | 68 Participants |
Secondary
Length of Hospital Stay
Time frame: After surgery until hospital discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blood Transfusion Triggers of 24% Hematocrit Value | Length of Hospital Stay | 10 days |
| Blood Transfusion Triggers of 28% Hematocrit Value | Length of Hospital Stay | 10 days |
Secondary
Length of ICU Stays
Time frame: After surgery until discharged from ICU
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blood Transfusion Triggers of 24% Hematocrit Value | Length of ICU Stays | 67 hours |
| Blood Transfusion Triggers of 28% Hematocrit Value | Length of ICU Stays | 66 hours |
Secondary
Number of Blood Transfusion
Time frame: From induction to the end of sugery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Blood Transfusion Triggers of 24% Hematocrit Value | Number of Blood Transfusion | 1 times |
| Blood Transfusion Triggers of 28% Hematocrit Value | Number of Blood Transfusion | 1 times |
Secondary
Postoperative Atrial Fibrillation
Time frame: After surgery until hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blood Transfusion Triggers of 24% Hematocrit Value | Postoperative Atrial Fibrillation | 33 Participants |
| Blood Transfusion Triggers of 28% Hematocrit Value | Postoperative Atrial Fibrillation | 45 Participants |
Secondary
Prolonged Postoperative Ventilation
On ventilation \>24 hours after surgery
Time frame: After surgeyr until hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Blood Transfusion Triggers of 24% Hematocrit Value | Prolonged Postoperative Ventilation | 22 Participants |
| Blood Transfusion Triggers of 28% Hematocrit Value | Prolonged Postoperative Ventilation | 18 Participants |