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Evaluation and Comparison of Using Low-Dose Aprotinin and Tranexamic Acid in CABG: a Double Blind Randomized Clinical
Mohammad Hassan Ghaffari Nejad1, Bahador Baharestani, Rostam Esfandiari
1Shaheed Rajaiee Cardiovascular Research Center, Tehran, Iran.
Insights
Low-dose aprotinin and tranexamic acid effectively reduce bleeding and transfusion needs in coronary artery bypass graft (CABG) surgery without increasing complications or mortality.
Area of Science:
- Cardiovascular Surgery
- Anesthesiology
- Pharmacology
Background:
- Cardiovascular operations carry an inherent risk of bleeding, often necessitating blood transfusions.
- Minimizing post-bypass bleeding and transfusion requirements is a significant medical and economic concern.
Purpose of the Study:
- To evaluate the efficacy of low-dose aprotinin and tranexamic acid in reducing bleeding and transfusion needs during on-pump coronary artery bypass graft (CABG) surgery.
- To compare these agents against a placebo in a double-blind, randomized trial.
Main Methods:
- A double-blind, randomized, placebo-controlled trial involving 150 patients undergoing on-pump CABG surgery.
- Patients were divided into three groups (50 each): low-dose aprotinin, tranexamic acid, or placebo.
- Outcomes including chest tube drainage, reoperation for bleeding, and complications were evaluated.
Main Results:
- Both low-dose aprotinin and tranexamic acid significantly reduced chest tube drainage compared to placebo (p < 0.001).
- No statistically significant differences were observed between the groups regarding age, sex, comorbidities, reoperation for bleeding, or overall complications.
- All patients, regardless of treatment group, experienced uneventful hospital discharges with no mortality.
Conclusions:
- Low-dose aprotinin and tranexamic acid are effective in reducing blood loss and transfusion requirements in CABG patients.
- These agents can be used safely, as they do not significantly increase mortality or morbidity.
Background:
Cardiovascular operations are associated with an inherent bleeding tendency that sometimes leads to severe bleeding and transfusion requirement. Pharmacological intervention to minimize post-bypass bleeding and blood product transfusions has received increasing attention from both medical and economic viewpoints.
Methods:
This double-blind, randomized, placebo-controlled clinical trial recruited three groups of patients (each group consisting of 50 patients) undergoing on-pump coronary artery bypass graft surgery (CABG) and blindly randomized them to receive either low aprotinin, tranexamic acid, or placebo. The results were, subsequently, evaluated and compared between the groups. All the patients were operated on by one surgeon and the same surgery team.
Results:
THE FOLLOWING VARIABLES WERE SIMILAR BETWEEN THE GROUPS, AND THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE GROUPS IN TERMS OF THESE VARIABLES: age (p value = 0.308), sex (p value = 0.973), hyperlipidemia (p value = 0.720), hypertension (p value = 0.786), smoking (p value = 0.72), and diabetes (p value = 0.960). The amounts of drainage from chest tubes were less in the aprotinin and tranexamic acid groups than the amount in the placebo group; the difference was statistically important (p value < 0.001). There was no statistically significant difference with respect to need for reoperation for bleeding between the three groups (p value = 0.998). Complications following surgery in the three groups were statistically the same and not significantly different. All the complications (myocardial infarction, pericardial effusion, neurological complication and renal complication) had a good course, and all the patients were discharged from the hospital uneventfully. There was no mortality in any group.
Conclusion:
Low-dose aprotinin and tranexamic acid can significantly reduce blood loss and transfusion requirement in CABG without importantly increasing mortality and morbidity.
