C.Surgical Procedure; Cardiac
Conditions
Keywords
tranexamic acid, cardiac surgery, cardiopulmonary bypass
Brief summary
Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is still unknown. We use three different doses to find which is the optimum dose of tranexamic acid in cardiopulmonary bypass cardiac surgery.
Interventions
DRUGTranexamic Acid
The loading doses were given in 15 minutes when incision.
Sponsors
Hongwen Ji
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Noncyanotic congenital heart disease patients requiring cardiac surgeries under cardiopulmonary bypass * Rheumatic or recessive valvular disease patients requiring valvular repair or replacement under cardiopulmonary bypass * Coronary artery disease patients requiring coronary artery bypass graft under cardiopulmonary bypass
Exclusion criteria
* Non-primary and emergency cardiac surgery * Disorder in coagulation function before surgery * Anemia before surgery * Definite liver and renal dysfunction * History of stroke * Pregnancy and lactation * Disabled in spirit or law * Fatal conditions such as cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative Blood Loss | 24hrs postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Needs Allogenic Transfusion | on the 7th day postoperatively |
Other
| Measure | Time frame |
|---|---|
| Rate of Reexploration for Bleeding | on the 7th day postoperatively |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Small Dose 10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision. | 319 |
| Medium Dose 20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision. | 318 |
| Large Dose 30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery
Tranexamic Acid: The loading doses were given in 15 minutes when incision. | 318 |
| Total | 955 |
Baseline characteristics
| Characteristic | Small Dose | Medium Dose | Large Dose | Total |
|---|---|---|---|---|
| Age, Continuous | 53.1 years STANDARD_DEVIATION 10.9 | 53.2 years STANDARD_DEVIATION 11.8 | 53.1 years STANDARD_DEVIATION 11.6 | 53.1 years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 137 Participants | 138 Participants | 138 Participants | 413 Participants |
| Sex: Female, Male Male | 182 Participants | 180 Participants | 180 Participants | 542 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 319 | 3 / 318 | 2 / 318 |
| serious Total, serious adverse events | 34 / 319 | 42 / 318 | 29 / 318 |
Outcome results
Primary
Postoperative Blood Loss
Time frame: 24hrs postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Small Dose | Postoperative Blood Loss | 520 ml |
| Medium Dose | Postoperative Blood Loss | 490 ml |
| Large Dose | Postoperative Blood Loss | 450 ml |
Secondary
Number of Participants Needs Allogenic Transfusion
Time frame: on the 7th day postoperatively
Other Pre-specified
Rate of Reexploration for Bleeding
Time frame: on the 7th day postoperatively