Effect of Prophylactic Tranexamic Acid Administration on Perioperative Bleeding and Thromboembolic Outcomes in Patients Undergoing Bariatric Surgery: A Retrospective Observational Cohort Study
| Registry | NCT07754396, acronym TXA-BARI |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 140 (Actual) |
| Sponsor | G.Gennimatas General Hospital (Other) |
| Conditions | Morbid Obesity, Perioperative Hemorrhage, Obesity, Tranexamic Acid, Postoperative Hemorrhage |
| Dates | start 2024-05-01, primary completion 2026-04-30, completion 2026-04-30, first posted 2026-08-10, last updated 2026-08-10 |
| Locations | 1 site in Greece |
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Postoperative bleeding is an important complication of bariatric surgery and may lead to increased morbidity, prolonged hospitalization, and higher healthcare costs. Tranexamic acid (TXA) has been shown to reduce perioperative blood loss in several surgical specialties; however, evidence regarding its effectiveness and safety in bariatric surgery remains limited.
This retrospective observational cohort study aims to evaluate the effect of prophylactic intraoperative tranexamic acid administration on perioperative bleeding in patients undergoing bariatric surgery. The primary objective is to assess the postoperative decrease in hemoglobin levels. Secondary objectives include evaluating the need for blood transfusion, length of hospital stay, and the incidence of thromboembolic complications, including deep vein thrombosis, pulmonary embolism, portal vein thrombosis, and acute coronary syndrome.
The study includes patients who underwent bariatric surgery at G. Gennimatas General Hospital between May 1, 2024, and April 30, 2026.
This is a single-center retrospective observational cohort study including patients who underwent bariatric surgery at G. Gennimatas General Hospital between May 1, 2024, and April 30, 2026.
The study compares patients who received prophylactic intraoperative tranexamic acid with those who did not receive tranexamic acid. Demographic characteristics, comorbidities, laboratory findings, perioperative variables, and postoperative outcomes will be collected from medical records.
The primary outcome is the postoperative reduction in hemoglobin concentration following bariatric surgery.
Secondary outcomes include blood transfusion requirements, length of hospital stay, timing and type of postoperative thromboprophylaxis, and thromboembolic complications, including deep vein thrombosis, pulmonary embolism, portal vein thrombosis, and acute coronary syndrome.
Patients with known thrombophilia, coagulation disorders, chronic anticoagulant or antiplatelet therapy, previous pulmonary embolism, coronary artery disease, chronic kidney disease, or hypersensitivity to tranexamic acid will be excluded.
All study data will be collected retrospectively from existing medical records and will be anonymized before analysis in accordance with institutional requirements and applicable data protection regulations.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Tranexamic Acid Group | Patients undergoing bariatric surgery who received prophylactic intraoperative tranexamic acid as part of routine clinical practice. | ||
| Control Group | No Tranexamic Acid Group |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Adults (≥18 years of age). * Patients who underwent bariatric surgery at G. Gennimatas General Hospital between May 1, 2024, and April 30, 2026. * Availability of complete perioperative and postoperative medical records. Exclusion Criteria: * Known thrombophilia. * Coagulation disorders. * Chronic anticoagulant or antiplatelet therapy. * Previous pulmonary embolism. * Coronary artery disease. * Chronic kidney disease. * Known hypersensitivity to tranexamic acid.
| Facility | City | Country | Status |
|---|---|---|---|
| General Hospital of Athens G. Gennimatas | Athens | Greece |