Coronary Artery Bypass, Coronary Artery Disease, Erythrocyte Transfusion
Conditions
Keywords
Allogenic Blood Use, Total Blood Loss, Reinfusion of Washed Shed Blood
Brief summary
The investigators' hypothesis is that restriction of circulating fluids in comparison to a liberal fluid administration policy would lead to a reduction of allogenic red blood cells exposure in patients undergoing cardiopulmonary bypass (CPB) for primary coronary artery bypass graft supported by reinfusion of washed shed blood from thoracic cavities.
Detailed description
192 patients operated under equal conditions were assigned prospectively and randomly either for a restrictive protocol for intravenous fluid administration (group A, 100 patients) or not (group B, 92 patients). Transfusion guidelines were common for the two groups. The volumes of intravenous fluids, priming, extra volume on pump and cardioplegic solution and the volume of urine were recorded. Net erythrocyte volume loss was calculated. The number of the transfused PRC was analyzed as a continuous variable. Transfusion was analyzed as a categorical characteristic. Analysis employed Student's two-tailed t-test, t-paired test and chitest.
Interventions
PROCEDUREFluid Restriction Policy
Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary bypass
PROCEDUREFree fluid infusion
Free fluid infusion unless Hb\< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass
Sponsors
Larissa University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Ejection fraction (EF) of left ventricle (LV) \> 35% * Preoperative serum Creatinine \< 150 μmol/l * Preoperative Haemoglobin \> 10/dl * Peripheral anastomosis scheduled =\< 3
Exclusion criteria
* redo bypass-emergency operations * prior coronal stenting * active congestive heart failure * documented Myocardial Infraction within the previous 6 weeks * NYHA class \> 3 * Carotid stenosis \> 50% * CVA * INR \> 1.5 * chronic obstructive pulmonary disease (COPD) * Steroid therapy-chronic inflammatory process * Use of aprotinin or tranexamic acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Number of Packed Red Cells Units Transfused During Hospital Stay | 20 months |
Countries
Greece
Participant flow
Recruitment details
This prospective study was conducted in our University Hospital over a 20-month period, after approval from the Institution Ethics committee, and written informed consent was obtained from all patients before entering the study. All the participants were patients of the Cardio-Thoracic Clinic of our Hospital.
Pre-assignment details
Exclusion criteria were emergency or re-do operations, operations starting after 18.00, administration of tissue plasminogen activator (TPA) or other thrombolytic medications, pre-existing hematologic disease or coagulation abnormality, advanced cirrhosis, renal failure, preoperative blood product transfusion, combined cardiac and carotid surgery.
Participants by arm
| Arm | Count |
|---|---|
| RESTRICTED FLUIDS Infusion of Hes 130/0.4 up to 500 ml | 100 |
| FREE FLUIDS Free fluid infusion unless Hb\< 6g/dl(allogenic blood use) | 92 |
| Total | 192 |
Baseline characteristics
| Characteristic | FREE FLUIDS | RESTRICTED FLUIDS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 92 Participants | 100 Participants | 192 Participants |
| Age Continuous | 65.5 years STANDARD_DEVIATION 8.3 | 66 years STANDARD_DEVIATION 7.9 | 65.77 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment Greece | 92 participants | 100 participants | 192 participants |
| Sex: Female, Male Female | 16 Participants | 17 Participants | 33 Participants |
| Sex: Female, Male Male | 76 Participants | 83 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 100 | 2 / 92 |
| serious Total, serious adverse events | 20 / 100 | 18 / 92 |
Outcome results
Primary
Mean Number of Packed Red Cells Units Transfused During Hospital Stay
Time frame: 20 months
Population: Patients between ages 18-85 undergoing elective cardiac surgery under cardiopulmonary bypass
| Arm | Measure | Value (MEAN) |
|---|---|---|
| RESTRICTED FLUIDS | Mean Number of Packed Red Cells Units Transfused During Hospital Stay | 1.13 packed red cells units |
| FREE FLUIDS | Mean Number of Packed Red Cells Units Transfused During Hospital Stay | 1.91 packed red cells units |
Comparison: Sample size calculation was based on a two-sided alpha error of .05 and 80% power. After applying the protocol in two equal groups of 10 patients, the analysis showed that the study requires 60 patients per group. However, we decided to enroll up to 100 patients per group to allow for patient attrition or missing data, and also in order to look for differences with regards to transfusion between patient subgroups.p-value: <0.0595% CI: [0.189, 0.569]t-test, 2 sided
Comparison: Null hypothesis :restrictive fluid protocol does not have any effect concerning the mean number of PRC units transfused.p-value: <0.0595% CI: [0.465, 1.129]Regression, Linear