BAR-TAX - Tranexamic Acid in Bariatric Surgery.

NCT07401394 | Active Not Recruiting

• 2 other identifiers: GVM_BAR-TAXBAR-TAX_GVM
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery; Bariatric Patients; Bariatric Surgery Complications; Bleeding; Tranexamic Acid

Outcome Measures

Primary Outcomes (1)

• TAX and bleeding in bariatric surgery

  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 Outcomes (5)

• Hidden blood loss

  12 months

• Transfusion rate

  12 months

• Rate of re-operation

  12 months

• Incidence of complications

  12 months

• Hospital stay

  12 months

Study Arms (1)

BAR_TAX

EXPERIMENTAL

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)

Interventions

Tranexamic Acid (TXA) DRUG

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.

BAR_TAX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Santa Maria Hospital - GVM Care & Research: lead

Study Sites (1)

Santa Maria Hospital - GVM

Bari, BA, 70124, Italy

Location

Related Publications (4)

• 't Hart JWH, Noordman BJ, Wijnand JMA, Biter LU, Verbrugge SJC, Birnie E, Dunkelgrun M, Huisbrink J, Apers JA. Peroperative administration of tranexamic acid in sleeve gastrectomy to reduce hemorrhage: a double-blind randomized controlled trial. Surg Endosc. 2023 Oct;37(10):7455-7463. doi: 10.1007/s00464-023-10232-5. Epub 2023 Jul 3.

  PMID: 37400687 BACKGROUND

• Bieniaszewski K, Proczko-Stepaniak M, Wilczynski M, Nowicki P, Bigda J, Szymanski M. Effectiveness of Tranexamic Acid in Reducing Hidden Blood Loss During Laparoscopic Sleeve Gastrectomy: A Randomized Clinical Trial. J Clin Med. 2025 Apr 26;14(9):3010. doi: 10.3390/jcm14093010.

  PMID: 40364042 BACKGROUND

• Lech P, Michalik M, Waczynski K, Osowiecka K, Dowgiallo-Gornowicz N. Effectiveness of prophylactic doses of tranexamic acid in reducing hemorrhagic events in sleeve gastrectomy. Langenbecks Arch Surg. 2022 Nov;407(7):2733-2737. doi: 10.1007/s00423-022-02630-5. Epub 2022 Aug 3.

  PMID: 35920900 BACKGROUND

• Brito RM, Oliveira CMB, Moura ECR, Campelo GP, Lima RC, Fe CSM, Sousa TM, Oliveira EJSG, Dibai Filho AV, Leal PDC. Tranexamic acid effects in postoperative bleeding outcomes in laparoscopic sleeve gastrectomy: a controlled study. Acta Cir Bras. 2022 Oct 10;37(7):e370702. doi: 10.1590/acb370702. eCollection 2022.

  PMID: 36228297 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Antonio Braun, MD

  GVM Care & Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Patients treated with perioperative tranexamic acid will be compared with a historical cohort managed under the previous institutional protocol without TXA.

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 10, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

IT (1)