Bariatric SurgeryBAR-TAXNCT07401394
BAR-TAX - Tranexamic Acid in Bariatric Surgery.
A study testing Tranexamic Acid (TXA) in people with Bariatric Surgery and Bariatric Patients, run by Santa Maria Hospital - GVM Care & Research at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery, Bariatric Patients, Bariatric Surgery Complications
- What is being tested?
- Tranexamic Acid (TXA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Both sexes
- BMI ≥30 kg/m²
- Candidates for primary or revisional bariatric surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bariatric Surgery, Bariatric Patients, Bariatric Surgery Complications, Bleeding, Tranexamic Acid
- Being tested
- Tranexamic Acid (TXA)
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tranexamic Acid (TXA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (5)
Hidden blood loss
Reduction in hemoglobin drop at 24 h and 72 h (ΔHb) and estimation of hidden blood loss.
Measured: 12 months
Transfusion rate
Transfusion rate (units of packed red blood cells) and indication.
Measured: 12 months
Rate of re-operation
Rate of re-operation/hemostatic revision or hemostatic procedures (endoscopy/interventional radiology).
Measured: 12 months
Incidence of complications
Incidence of venous thromboembolic events at 30 days. Incidence of complications at 30 days (Clavien-Dindo classification, late hemorrhagic complications).
Measured: 12 months
Hospital stay
Length of hospital stay and readmissions.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Dec 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients treated with perioperative tranexamic acid will be compared with a historical cohort managed under the previous institutional protocol without TXA.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santa Maria Hospital - GVM Care & Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Libero Luca, Santa Maria Hospital - GVM Care & Research
- Investigators
- Antonio Braun, MD, Principal investigator, GVM Care & Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401394
- Sponsor's protocol ID
- GVM_BAR-TAX
- Other IDs
- BAR-TAX_GVM
- Acronym
- BAR-TAX
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
'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.
PubMed 37400687Bieniaszewski 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.
PubMed 40364042Lech 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.
PubMed 35920900Brito 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.
PubMed 36228297
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07401394
- Acronym / sponsor ID
- BAR-TAX / GVM_BAR-TAX
- Conditions
- Bariatric Surgery, Bariatric Patients, Bariatric Surgery Complications, Bleeding, Tranexamic Acid
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Santa Maria Hospital - GVM Care & ResearchUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients treated with perioperative tranexamic acid will be compared with a historical cohort managed under the previous institutional protocol without TXA.
| Arm | Type | Receives |
|---|---|---|
| BAR_TAX | Experimental | Drug: Tranexamic Acid (TXA)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Both sexes
- BMI ≥30 kg/m²
- Candidates for primary or revisional bariatric surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | BAR_TAX |
Primary outcome
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).
5 secondary outcomes
Hidden blood loss
Time frame: 12 months
Transfusion rate
Time frame: 12 months
Rate of re-operation
Time frame: 12 months
Incidence of complications
Time frame: 12 months
Hospital stay
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 37400687'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.
- Background: PubMed 40364042Bieniaszewski 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.
- Background: PubMed 35920900Lech 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.
- Background: PubMed 36228297Brito 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.
- Individual participant dataSharing planned: Undecided
Related trials for Bariatric Surgery
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruiting
Effectiveness of an Early Postoperative Nurse-Led, Individualized Counseling Program on Lifestyle Adherence After Bariatric Surgery: A Randomized Controlled Trial
Lifestyle Adherence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Braun, MD principal investigator
GVM Care & Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid (TXA) in people with Bariatric Surgery and Bariatric Patients, run by Santa Maria Hospital - GVM Care & Research at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TAX and bleeding in bariatric surgery (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07401394, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.