Perioperative Administration of Tranexamic Acid to Reduce Hemorrhage in Morbid Obesity Patients Undergoing Gastric Bypass: A Randomized Controlled Trial

The primary objective of this study is to evaluate the efficacy of **tranexamic acid** (TXA) in reducing haemorrhage rates during gastric bypass surgery in patients with **morbid obesity**. This is clinically relevant as excessive bleeding during such procedures can lead to increased morbidity, prolonged hospital stays, and higher healthcare costs. By potentially reducing intraoperative blood loss, TXA could improve surgical outcomes and patient safety in this population.

The clinical trial focuses on **morbid obesity** and involves participants who are eligible for bariatric surgery according to the IFSO guidelines. The study population includes both male and female subjects aged 18 years or older. Participants are those undergoing a laparoscopic gastric bypass, either Roux-en-Y or one-anastomosis. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Lifestyle considerations such as diet and physical activity are not specified in the available data.

The clinical trial is designed to evaluate the efficacy of **tranexamic acid** in reducing haemorrhage rates in patients undergoing gastric bypass surgery for **morbid obesity**. This study is a randomized, controlled trial with a double-blind design, ensuring that neither the participants nor the investigators are aware of the treatment assignments. The trial is expected to span from April 28, 2023, to December 1, 2025, with participant involvement lasting for a maximum of one day, corresponding to the perioperative period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (18 years or older) and suitability for bariatric surgery according to the IFSO guidelines. The primary endpoint of the study is the need for postoperative intervention due to haemorrhage, defined by the administration of packed red blood cells or surgical, radiological, or endoscopic intervention. Secondary endpoints include the use of hemostatic devices, blood loss measurements, and postoperative complications such as venous thromboembolism (VTE) and side effects of **tranexamic acid**.

The study involves the administration of **tranexamic acid** or a placebo (sodium chloride) intravenously during the surgery. The maximum daily dose for **tranexamic acid** is 1500 mg, while the placebo is administered at a maximum of 100 ml. Participants will be monitored closely during the perioperative period, and any adverse events or complications will be documented. The end-of-study visit will occur postoperatively to assess the outcomes and any potential side effects.

Participants may be withdrawn from the study if they experience significant adverse reactions, if they withdraw consent, or if they are unable to comply with the study protocol. The trial aims to provide valuable insights into the potential benefits of **tranexamic acid** in reducing surgical bleeding in patients with **morbid obesity** undergoing gastric bypass surgery.

The clinical trial involves the administration of **tranexamic acid**, an antifibrinolytic agent, as the experimental medication. Tranexamic acid is provided in the form of a **solution for infusion**. The active substance, tranexamic acid, is of chemical origin and is administered intravenously. The maximum daily dose is 1500 mg, with a total dose not exceeding 1500 mg over the treatment period. The administration is conducted over a maximum treatment period of one day. The primary objective of using tranexamic acid in this trial is to evaluate its efficacy in reducing haemorrhage rates during gastric bypass surgery.

In addition to the experimental treatment, **sodium chloride** is used as a comparator treatment in the study. Sodium chloride is also provided as a solution for infusion and is administered intravenously. The maximum daily dose for sodium chloride is 100 ml, with a total dose not exceeding 100 ml over the treatment period. Similar to tranexamic acid, the administration of sodium chloride is conducted over a maximum treatment period of one day. Sodium chloride serves as an intravenous fluid in this trial, providing a baseline for comparison against the effects of tranexamic acid.

Efficacy in the clinical trial titled "Peroperative Administration of Tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage (PATRY study): a randomized controlled trial" will be assessed using both primary and secondary endpoints. The primary endpoint is the occurrence of postoperative intervention due to **haemorrhage**, which is defined as the administration of packed red blood cells or the need for surgical, radiological, or endoscopic intervention. Secondary endpoints include the use of hemostatic staple devices, the amount of hemostatic staples used, the use of fibrin sealant, the amount of blood loss peroperatively, the decrease in hemoglobin levels postoperatively, and the increase in heart rate postoperatively. Additional secondary endpoints are the occurrence of hematemesis and/or melena, rates of postoperative hemorrhage requiring extra hemoglobin monitoring or administration of tranexamic acid (TXA) and/or reinterventions, rates of venous thromboembolism (VTE), other complications, hospitalization time, pain score, side effects of TXA, and the duration of the primary surgery.