BAR-TAX - Tranexamic Acid in Bariatric Surgery. (BAR-TAX)

February 10, 2026 updated by: Libero Luca, Santa Maria Hospital - GVM Care & Research

BAR-TAX - Tranexamic Acid in Bariatric Surgery. Use of Tranexamic Acid and Bleeding Management in Bariatric Surgery: A Prospective Study in a High-Volume Center.

Perioperative bleeding is a relevant complication in bariatric surgery and may lead to hemoglobin decrease, blood transfusions, reinterventions, prolonged hospital stay, and increased healthcare costs. Tranexamic acid (TXA), an antifibrinolytic agent, has demonstrated efficacy in reducing surgical bleeding in several surgical specialties, with a favorable safety profile when appropriately used. However, evidence in bariatric surgery remains limited, particularly considering the intrinsically increased thromboembolic risk of obese patients.

The BAR-TAX study is a prospective, single-center study conducted in a high-volume bariatric surgery center, aiming to evaluate the efficacy and safety of perioperative TXA administration compared with standard care without TXA. The primary objective is to assess whether TXA reduces the incidence of clinically significant bleeding within 48-72 hours after bariatric surgery. Secondary objectives include evaluation of hemoglobin drop, transfusion rates, need for hemostatic procedures or reoperation, thromboembolic events, postoperative complications, length of hospital stay, readmissions, and TXA-related adverse events.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Bariatric surgery, including procedures such as Sleeve Gastrectomy, Roux-en-Y Gastric Bypass, Transit Bipartition, and revisional surgery, is associated with a non-negligible risk of perioperative and postoperative bleeding. Clinically significant bleeding may result in adverse outcomes such as increased transfusion requirements, reintervention, prolonged hospitalization, and higher healthcare resource utilization. At the same time, obese patients represent a population at increased baseline risk for venous thromboembolism, requiring careful balancing between bleeding prevention and thromboembolic safety.

Tranexamic acid (TXA) is an antifibrinolytic agent that inhibits plasminogen activation and fibrin degradation, thereby stabilizing clot formation. Its perioperative use has been widely adopted in orthopedic, cardiac, and trauma surgery, with consistent evidence supporting reductions in blood loss and transfusion requirements without a significant increase in thromboembolic events when used according to established protocols. Emerging data in bariatric surgery suggest similar benefits; however, robust prospective data in this specific population are still limited.

The BAR-TAX study is designed as a prospective, non-funded, single-center observational study conducted in a high-volume bariatric surgery unit. Adult patients (≥18 years) with a BMI ≥30 kg/m² undergoing primary or revisional bariatric surgery will be eligible for inclusion. Patients with recent venous thromboembolism, major uncontrolled thrombophilia, severe renal insufficiency, uncontrolled seizure disorders, known TXA allergy, or pregnancy will be excluded.

Patients in the TXA group will receive a standardized perioperative TXA regimen consisting of 2 g administered intravenously during anesthetic induction, followed by 2 g at 8 hours and 2 g at 12 hours postoperatively. All patients will be managed according to standardized perioperative care pathways, including optimized intraoperative hemostasis, venous thromboembolism prophylaxis based on institutional protocols, ERABS principles, and standardized postoperative monitoring.

The primary endpoint is the incidence of clinically significant bleeding within 48-72 hours after surgery, defined by the presence of at least one of the following: hemoglobin drop ≥2 g/dL associated with clinical signs, need for blood transfusion, bleeding requiring endoscopic, radiologic, or surgical intervention, or hemodynamic instability attributable to bleeding. Secondary endpoints include hemoglobin variation at 24 and 72 hours, estimated hidden blood loss, transfusion rate and indications, need for reintervention or hemostatic procedures, 30-day venous thromboembolic events, postoperative complications classified according to Clavien-Dindo, length of hospital stay, readmissions, and TXA-related adverse events such as seizures or allergic reactions.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BA
      • Bari, BA, Italy, 70124
        • Santa Maria Hospital - GVM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Both sexes
  • BMI ≥30 kg/m²
  • Candidates for primary or revisional bariatric surgery

Exclusion Criteria:

  • Recent history of DVT/PE (e.g., <12 months) or major thrombophilia not adequately managed
  • Severe renal insufficiency (e.g., eGFR <30 mL/min/1.73 m²) or need for unmanageable dose adjustment
  • History of uncontrolled seizures/epilepsy (dose-dependent risk)
  • Known allergy to TXA
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BAR_TAX
The TAX arm includes patients undergoing bariatric surgery who receive perioperative tranexamic acid according to the BAR-TAX protocol. Outcomes will be compared with a historical control arm consisting of patients treated under the previous institutional protocol without tranexamic acid administration.
Drug: Tranexamic Acid (TXA)
Tranexamic acid is administered intravenously according to a standardized perioperative regimen. Patients receive 2 g of tranexamic acid diluted in 250 mL of normal saline during anesthetic induction, followed by 2 g intravenously at 8 hours and 12 hours postoperatively. All patients are managed according to standardized perioperative care pathways, including venous thromboembolism prophylaxis and ERABS protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TAX and bleeding in bariatric surgery
Time Frame: 12 months
To evaluate whether perioperative TAX use reduces the incidence of clinically significant bleeding within 48-72 hours after surgery (defined as at least one of the following: hemoglobin drop ≥2 g/dL with clinical signs, need for transfusion, bleeding requiring a procedure/endoscopy/surgery, hemodynamic instability attributable to bleeding).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hidden blood loss
Time Frame: 12 months
Reduction in hemoglobin drop at 24 h and 72 h (ΔHb) and estimation of hidden blood loss.
12 months
Transfusion rate
Time Frame: 12 months
Transfusion rate (units of packed red blood cells) and indication.
12 months
Rate of re-operation
Time Frame: 12 months
Rate of re-operation/hemostatic revision or hemostatic procedures (endoscopy/interventional radiology).
12 months
Incidence of complications
Time Frame: 12 months
Incidence of venous thromboembolic events at 30 days. Incidence of complications at 30 days (Clavien-Dindo classification, late hemorrhagic complications).
12 months
Hospital stay
Time Frame: 12 months
Length of hospital stay and readmissions.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santa Maria Hospital - GVM Care & Research

Investigators

  • Principal Investigator: Antonio Braun, MD, GVM Care & Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GVM_BAR-TAX
  • BAR-TAX_GVM (Other Identifier: Scientific Board GVM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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