NCT06038981

Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy

Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy - a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Enhanced recovery after bariatric surgery imposes a significant reduction in length of hospital stay. However beneficial for the overall recovery it reduces the hospital observation time. after a laparoscopic surgery during which one of the longest resection line in surgery or anastomosis are created. Therefore, discovering possible safe and effective ways of pharmacologically reducing surgical blood loss and reducing the risk of postoperative bleeding would be an invaluable addition to the protocol. The systemic use of tranexamic acid (TXA) has been shown to be effective in many types of surgery, reducing the incidence of post-operative bleeding and thereby reducing the rate of reoperation.

Detailed description

Aim: To evaluate if TXA systemic administration reduces postoperative blood loss in bariatric surgeriessleeve gastrectomy operation. Material and methods: A single-blind randomized clinical trial in the high-volume bariatric center of excellence. Patients undergoing highly standardized bariatric procedures, meeting the inclusion and exclusion criteria were included in the study, sample size determined by power study evaluation. Randomization scheme was a weekly surgery schedule. Patients were randomized to 2 groups: TXA (administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced) od CG (no tranexamic acid administration). Patients were evaluated on the postoperative day 1 by standard lab tests included in the center's protocol, additionally measuring the volume of drainage and heamoglobin concentration in the drainage sample. 1-month follow-up observation involving interviewing, examining and conducting lab tests of the study group was provided to determine the safety profile and possible occurrence of TXA complications.

Conditions

• Hemorrhage, Surgical
• Bariatric Surgery
• Tranexamic Acid

Interventions

Type	Name	Description
DRUG	Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced	The systemic use of tranexamic acid (TXA) has been shown to be effective in many types of surgery, reducing the incidence of post-operative bleeding and thereby reducing the rate of reoperation. To evaluate if TXA systemic administration reduces postoperative blood loss in bariatric surgeries (sleeve gastrectomy operation)

Timeline

• Start date: 2022-07-04
• Primary completion: 2023-06-28
• Completion: 2023-06-28
• First posted: 2023-09-15
• Last updated: 2023-09-22

Locations

1 site across 1 country: Poland