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Study on Tranexamic Acid and Sodium Chloride to Reduce Bleeding in Gastric Bypass Surgery for Patients with Severe Obesity

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called tranexamic acid in patients with morbid obesity who are undergoing a type of weight-loss surgery known as gastric bypass. Morbid obesity is a condition where a person has an excessive amount of body fat, which can lead to various health problems. The purpose of the study is to see if using tranexamic acid during the surgery can help reduce bleeding. Tranexamic acid is given as a solution through a vein, which is known as intravenous use.

In this study, some patients will receive tranexamic acid, while others will receive a placebo, which is a substance with no active medication. Another substance used in the study is sodium chloride, which is a common salt solution often used in medical settings. The study will compare the outcomes of those who receive tranexamic acid with those who receive the placebo to determine if there is a difference in the amount of bleeding during and after the surgery.

The study will follow patients through their surgery and recovery to monitor for any bleeding complications and other related outcomes. This includes checking for any need for additional medical interventions due to bleeding, as well as observing any side effects from the medication. The goal is to gather information that could help improve the safety and effectiveness of gastric bypass surgery for patients with morbid obesity.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as being 18 years or older and eligible for bariatric surgery according to specific guidelines.

    The study focuses on patients undergoing laparoscopic gastric bypass surgery, specifically Roux-en-Y or one-anastomosis procedures.

  2. Step 2

    Preoperative preparation

    Before surgery, preparation involves understanding the procedure and the role of tranexamic acid (TXA) in reducing bleeding during the operation.

    The administration of TXA is planned to occur during the surgery to help manage blood loss.

  3. Step 3

    Surgery and medication administration

    During the gastric bypass surgery, tranexamic acid is administered intravenously to help reduce the risk of bleeding.

    The surgery is performed laparoscopically, which is a minimally invasive technique.

  4. Step 4

    Postoperative monitoring

    After surgery, monitoring focuses on identifying any bleeding complications, such as the need for additional interventions or blood transfusions.

    Other factors monitored include blood loss, changes in hemoglobin levels, heart rate, and any signs of bleeding like vomiting blood or black stools.

  5. Step 5

    Evaluation of outcomes

    The study evaluates the effectiveness of TXA in reducing bleeding by assessing the need for further interventions and the overall blood loss during and after surgery.

    Secondary outcomes include the use of additional hemostatic devices, the duration of surgery, and any side effects from TXA.

  6. Step 6

    Completion of study participation

    Participation in the study concludes after all necessary data is collected and analyzed, with the estimated end date being December 1, 2025.

    The study aims to provide insights into the benefits of TXA in reducing surgical bleeding in patients with morbid obesity undergoing gastric bypass.

Who can join the trial?

4 criteria

  • Must be at least 18 years old.
  • Eligible for **bariatric surgery**. This is a type of surgery to help with weight loss.
  • Undergoing a **laparoscopic gastric bypass**. This is a surgery where small cuts are made in the belly to help with weight loss.
  • Both men and women can participate.

Who cannot join the trial?

3 criteria

  • Patients who are not considered to have morbid obesity. This means the study is only for those with a very high level of obesity.
  • Patients who are not within the specified age range for the study. The study has specific age requirements that participants must meet.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care, like children or those unable to make decisions for themselves, are not included.
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Investigated drugs

Tranexamic Acid (TXA) is a medication used in this trial to help reduce bleeding during gastric bypass surgery. It works by preventing the breakdown of blood clots, which can help control bleeding during and after the operation. The study is investigating whether using this medication during surgery can lower the risk of excessive bleeding in patients undergoing gastric bypass procedures.

What is already known about the treatment

Tranexamic Acid – Tranexamic acid is administered intravenously during surgery to help reduce bleeding. It is currently being studied in clinical trials for its effectiveness in reducing blood loss during gastric bypass surgery. The main therapeutic indication for tranexamic acid is to prevent excessive bleeding in various surgical procedures. At the molecular level, it works by inhibiting the breakdown of blood clots, which helps to maintain hemostasis. Tranexamic acid is classified as an antifibrinolytic agent.

Investigated diseases

Morbid Obesity – Morbid obesity is a condition characterized by an excessive accumulation of body fat, which significantly increases the risk of health problems. It is typically defined by a body mass index (BMI) of 40 or higher. This condition can lead to various complications, including diabetes, heart disease, and joint problems. Individuals with morbid obesity may experience difficulty in physical activities and may face social and psychological challenges. The progression of morbid obesity can lead to further health deterioration if not managed. It often requires comprehensive lifestyle changes and medical interventions to address the associated health risks.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513570-22-00Protocol code2022-031Estimated enrolment1 524 patientsSponsorSint Franciscus Vlietland Groep Stichting

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