Off Pump Coronary Artery Bypass Surgery
Conditions
Keywords
Tranexamic Acid, off-pump coronary Artery Bypass
Brief summary
The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass graphing (OPCAB) surgery.
Detailed description
Cardiac surgical procedures account for a large amount of allogeneic transfusion. Although postoperative bleeding seems to be attenuated by the avoidance of cardiopulmonary bypass (CPB), hemorrhagic complications are not completely eliminated and the consequent need for allogeneic transfusions are still major problems after OPCAB. Tranexamic acid, a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with CPB. About 30% of patients in OPCAB studies still receive a transfusion. A few small sample size studies concerned with the use of in OPCAB surgery, found that tranexamic acid appear to be effective in reducing postoperative bleeding, however, the results on transfusion requirements are still inconsistency. The purpose of this study was to evaluate the effects of tranexamic acid on the postoperative bleeding and transfusion requirements in a larger number of patients undergoing OPCAB surgery. In addition, the effect of tranexamic acid on mortality, morbidity and resource utilization was examined.
Interventions
DRUGTranexamic Acid
In tranexamic acid group, tranexamic acid, 1 g, was given 20 minutes before incision and 400 mg/h during the entire surgical procedure. The patients from control group were infused with normal saline as a placebo.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients for elective offpump coronary artery bypass surgery
Exclusion criteria
* A history of bleeding disorders * Active chronic hepatitis or cirrhosis * Chronic renal insufficiency (serum creatinine \> 2 mg/dL) * Preoperative anemia (Hb \< 10 g/dL) * Previous cardiac surgery * Myocardial infarction \< 7 days before surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Required Allogenic Red Blood Cells Transfusion | 1month postoperative |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative Chest Tube Drainage | 24h postoperative |
Countries
China
Participant flow
Recruitment details
From February 2009 to December 2009, 378 consecutive patients in Fuwai hospital scheduled for elective OPCAB were enrolled in the study. 118 patients were excluded for randomizatin because not meeting inclusion criteria(n=29), Refused to participate(n=81),and surgery cancelled(n=8).
Pre-assignment details
Of the 260 patients randomized, 130 were allocated to each group. 14 patients in tranexamic acid group and 15 in placebo group were withdrawn from the study for convert to on-pump surgery in course of surgery.
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid Group Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery. | 130 |
| Control Group The placebo consisted of an equivalent volume of saline solution. | 130 |
| Total | 260 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 14 | 15 |
Baseline characteristics
| Characteristic | Control Group | Tranexamic Acid Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 41 Participants | 44 Participants | 85 Participants |
| Age, Categorical Between 18 and 65 years | 89 Participants | 86 Participants | 175 Participants |
| Age Continuous | 60 years STANDARD_DEVIATION 8.5 | 60.5 years STANDARD_DEVIATION 8 | 60.4 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment China | 130 participants | 130 participants | 260 participants |
| Sex: Female, Male Female | 16 Participants | 26 Participants | 42 Participants |
| Sex: Female, Male Male | 114 Participants | 104 Participants | 218 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 116 | 0 / 115 |
| serious Total, serious adverse events | 0 / 116 | 0 / 115 |
Outcome results
Primary
Number of Patients Required Allogenic Red Blood Cells Transfusion
Time frame: 1month postoperative
Population: As predefined by study protocol,Fourteen patients in the tranexamic acid group and Fifteen in the placebo group were withdrawn from the study due to conversion to on-pump surgery during the course of surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tranexamic Acid Group | Number of Patients Required Allogenic Red Blood Cells Transfusion | 37 participants |
| Control Group | Number of Patients Required Allogenic Red Blood Cells Transfusion | 54 participants |
Comparison: Given that the frequency of RBC transfusion for OPCAB surgery is about 55%, to detect 35% reduction in TA group, with power=o.8 and α=0.05, a group of 107 patients in each arm is required. We estimated a crossover rate of 20%. The final sample size for randomization purposes increased to a total of 260 patients. The Chi-square test was used to test the differences in categorical variables between both groups.If one or more cells had an expected count less than 5, Fisher's Exact Test was used.p-value: <0.05Chi-squared
Secondary
Postoperative Chest Tube Drainage
Time frame: 24h postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid Group | Postoperative Chest Tube Drainage | 654 ml | Standard Deviation 224 |
| Control Group | Postoperative Chest Tube Drainage | 891 ml | Standard Deviation 295 |
p-value: <0.05t-test, 2 sided