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NCT Number: NCT07754396

Effect of Tranexamic Acid on Bleeding After Bariatric Surgery

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.

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Key information

Conditions

Morbid Obesity Body Weight Cardiovascular Diseases Embolism and Thrombosis Hemorrhage Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative Hemorrhage Postoperative Complications Postoperative Hemorrhage Signs and Symptoms Thromboembolism Tranexamic Acid Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Athens G. Gennimatas

Athens, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Postoperative Hemoglobin Reduction

    Time frame: 48 hours after surgery

    Difference between preoperative hemoglobin concentration and postoperative hemoglobin concentration following bariatric surgery, comparing patients who received prophylactic tranexamic acid with those who did not.

Secondary outcomes

  1. Blood Transfusion Requirement

    Time frame: Up to 4 weeks

    Requirement for perioperative blood transfusion.

  2. 2. Length of Hospital Stay

    Time frame: Up to 4 weeks

    Length of postoperative hospital stay.

  3. Thromboembolic Complications

    Time frame: Up to 4 weeks

    Incidence of thromboembolic events including deep vein thrombosis, pulmonary embolism, portal vein thrombosis, and acute coronary syndrome.

  4. Postoperative Hemoglobin at 24 Hours

    Time frame: 24 hours after surgery

    Postoperative hemoglobin concentration measured 24 hours after surgery.

Sponsors and collaborators

Lead sponsor

G.Gennimatas General Hospital

Other

Registry information

Official study title

Effect of Prophylactic Tranexamic Acid Administration on Perioperative Bleeding and Thromboembolic Outcomes in Patients Undergoing Bariatric Surgery: A Retrospective Observational Cohort Study

Acronym: TXA-BARI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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