Morbid ObesityTXA-BARINCT07754396
Effect of Tranexamic Acid on Bleeding After Bariatric Surgery
An observational study of Morbid Obesity and Perioperative Hemorrhage, run by G.Gennimatas General Hospital at 1 site in Greece.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity, Perioperative Hemorrhage, Obesity
- How many people
- 140 participants
- Where
- 1 siteGreece
- Study dates
- 1 May 2024to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult patients undergoing bariatric surgery at G. Gennimatas General Hospital between May 1, 2024, and April 30, 2026. Participants will be identified retrospectively from hospital medical records.
Who may be able to join
- 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.
Who cannot join
- Known thrombophilia.
- Coagulation disorders.
- Chronic anticoagulant or antiplatelet therapy.
- Previous pulmonary embolism.
- Coronary artery disease.
- Chronic kidney disease.
- Known hypersensitivity to tranexamic acid.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prophylactic Tranexamic Acid Administration on Perioperative Bleeding and Thromboembolic Outcomes in Patients Undergoing Bariatric Surgery: A Retrospective Observational Cohort Study
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.
Read the detailed description
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.
- Conditions
- Morbid Obesity, Perioperative Hemorrhage, Obesity, Tranexamic Acid, Postoperative Hemorrhage
- Keywords
- Tranexamic Acid, TXA, Bariatric Surgery, Sleeve Gastrectomy, Blood Loss, Thromboembolism, Enhanced Recovery After Surgery, ERAS
- Medical subject headings
- Obesity, Morbid, Obesity, Postoperative Hemorrhage, Hemorrhage, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Hemoglobin Reduction
Difference between preoperative hemoglobin concentration and postoperative hemoglobin concentration following bariatric surgery, comparing patients who received prophylactic tranexamic acid with those who did not.
Measured: 48 hours after surgery
Secondary outcomes (4)
Blood Transfusion Requirement
Requirement for perioperative blood transfusion.
Measured: Up to 4 weeks
2. Length of Hospital Stay
Length of postoperative hospital stay.
Measured: Up to 4 weeks
Thromboembolic Complications
Incidence of thromboembolic events including deep vein thrombosis, pulmonary embolism, portal vein thrombosis, and acute coronary syndrome.
Measured: Up to 4 weeks
Postoperative Hemoglobin at 24 Hours
Postoperative hemoglobin concentration measured 24 hours after surgery.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 May 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- G.Gennimatas General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panagiotis Chatzistavridis, G.Gennimatas General Hospital
- Investigators
- Amalia Douma, PHD, Principal investigator, General Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754396
- Sponsor's protocol ID
- TXA-BARI-RETRO-2026
- Other IDs
- 24049/28-07-2026
- Acronym
- TXA-BARI
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylactic Tranexamic Acid Administration on Perioperative Bleeding and Thromboembolic Outcomes in Patients Undergoing Bariatric Surgery: A Retrospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07754396
- Acronym / sponsor ID
- TXA-BARI / TXA-BARI-RETRO-2026
- Conditions
- Morbid Obesity, Perioperative Hemorrhage, Obesity, Tranexamic Acid, Postoperative Hemorrhage
- Keywords
- Tranexamic Acid, TXA, Bariatric Surgery, Sleeve Gastrectomy, Blood Loss, Thromboembolism, Enhanced Recovery After Surgery, ERAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- G.Gennimatas General HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 10 Aug 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing bariatric surgery at G. Gennimatas General Hospital between May 1, 2024, and April 30, 2026. Participants will be identified retrospectively from hospital medical records.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Known thrombophilia.
- Coagulation disorders.
- Chronic anticoagulant or antiplatelet therapy.
- Previous pulmonary embolism.
- Coronary artery disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Blood Transfusion Requirement
Time frame: Up to 4 weeks
2. Length of Hospital Stay
Time frame: Up to 4 weeks
Thromboembolic Complications
Time frame: Up to 4 weeks
Postoperative Hemoglobin at 24 Hours
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Amalia Douma, PHD principal investigator
General Hospital of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Perioperative Hemorrhage, run by G.Gennimatas General Hospital at 1 site in Greece.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 10 Aug 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative Hemoglobin Reduction (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.