NCT07754396

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
Last Updated

August 10, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 31, 2026

Last Update Submit

August 4, 2026

Conditions

Keywords

Tranexamic AcidTXABariatric SurgerySleeve GastrectomyBlood LossThromboembolismEnhanced Recovery After SurgeryERAS

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 hours after surgery

Secondary Outcomes (4)

  • Blood Transfusion Requirement

    Up to 4 weeks

  • 2. Length of Hospital Stay

    Up to 4 weeks

  • Thromboembolic Complications

    Up to 4 weeks

  • Postoperative Hemoglobin at 24 Hours

    24 hours after surgery

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Known thrombophilia.
  • Coagulation disorders.
  • Chronic anticoagulant or antiplatelet therapy.
  • Previous pulmonary embolism.
  • Coronary artery disease.
  • Chronic kidney disease.
  • Known hypersensitivity to tranexamic acid.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Athens G. Gennimatas

Athens, Greece

Location

MeSH Terms

Conditions

Obesity, MorbidObesityPostoperative HemorrhageHemorrhageThromboembolism

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesPostoperative ComplicationsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Amalia Douma, PHD

    General Hospital of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident anesthesiologist, Department of Anesthesiology, MSC in Clinical Pharmacology

Study Record Dates

First Submitted

July 31, 2026

First Posted

August 10, 2026

Study Start

May 1, 2024

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

August 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations