Cardiopulmonary Bypass
Conditions
Keywords
Cardiac Surgery, Antifibrinolytic agents, Blood transfusion, epsilon aminocaproic acid, tranexamic acid
Brief summary
We designed a prospective double-blinded randomized trial in an attempt to detect a difference between tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) in reducing transfusion in patients undergoing cardiac surgery.
Detailed description
Background: This study compares the efficacy of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in reducing blood loss in patients undergoing cardiac surgery. Methods: This was a double-blinded randomized trial. Patients (n=100) undergoing cardi- ac surgery were randomized to receive either TXA (10 mg/kg bolus followed by an infu- sion of 1mg/kg/hr) or EACA (150mg/kg bolus followed by an infusion of 20 mg/kg/hr). The primary outcome measure was a difference in transfusion amounts.
Interventions
DRUGTranexamic Acid
Infusion during cardiac surgery
Infusion during cardiac surgery
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is the subject 18 years of age or older? 2. Is the subject scheduled for primary cardiac surgery utilizing cardiopulmonary bypass(CPB)? 3. Is the subject more than 30 kg ( 66 lbs)? 4. Does subject understand English?
Exclusion criteria
1. Does the subject have existing coagulation defects (INR \> 1.5, platelets \< 100 ? 2. Does the subject have renal failure (defined as BUN/Cr ratio 20:1 ? 3. Does the subject have severe liver disease (AST & ALT\> 3x normal) ? 4. Is the subject having emergency cardiac surgery, complex aortic surgery, combination valve/CABG surgeries, or redo cardiac surgery? 5. Is the subject having any procedure where CPB is not anticipated? 6. Is the patient weight greater than 150 kg?
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Transfusion Amounts | 48 hours | The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2. |
Countries
United States
Participant flow
Recruitment details
Adult patients scheduled for primary cardiac surgery utilizing CPB at LLUMC . Subjects myst be \>30 kg, be able to understand English, and sign the consent form.Subjects will be recruited in the pre-admitting area prior to going to the PDCU area in the operating room.
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid Tranexamic Acid: Infusion during cardiac surgery | 40 |
| Aminocaproic Acid Aminocaproic Acid: Infusion during cardiac surgery | 42 |
| Total | 82 |
Baseline characteristics
| Characteristic | Total | Tranexamic Acid | Aminocaproic Acid |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 44 Participants | 22 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 18 Participants | 20 Participants |
| Age, Continuous | 63.51597561 years STANDARD_DEVIATION 12.79547179 | 63.79175 years STANDARD_DEVIATION 13.1260508 | 63.25333 years STANDARD_DEVIATION 12.62622 |
| Region of Enrollment United States | 82 Participants | 40 Participants | 42 Participants |
| Sex: Female, Male Female | 31 Participants | 16 Participants | 15 Participants |
| Sex: Female, Male Male | 51 Participants | 24 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 42 |
| serious Total, serious adverse events | 0 / 40 | 0 / 42 |
Outcome results
Primary
Total Transfusion Amounts
The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2.
Time frame: 48 hours
Population: equality in both arms
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid | Total Transfusion Amounts | 161 mililiters | Standard Deviation 274 |
| Aminocaproic Acid | Total Transfusion Amounts | 116 mililiters | Standard Deviation 296 |
Comparison: A power analysis based on the comparison of a 15% difference in total transfusion amounts up to POD 2 between the treatment groups indicated a total sample size of 80 with a power of 0.8, confidence interval 0.9, and p= 0.05.p-value: 0.35ANOVA