NCT05464394

Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass

Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass to Reduce Haemorrhage (PATRY Study): a Randomised Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,524 (estimated)
• Sponsor: Franciscus Gasthuis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The incidence of bleeding after metabolic surgery seems to increase. The administration of a drug (tranexamic acid) that can reduce bleeding could possibly also reduce bleeding after metabolic surgery. Objective: This study aims to determine whether administration of tranexamic acid before surgery can reduce postoperative bleeding in patients undergoing gastric bypass.

Conditions

• Hemorrhage
• Bleeding

Interventions

Type	Name	Description
DRUG	Tranexamic Acid Injection [Cyklokapron]	A set dose of 1500 mg will be used, based on the study population with morbid obesity. It will be administered intravenous dissolved in 100 ml sodium chloride 0.9% in a time frame of 15-30 minutes, with a maximum of 100 mg/min.
DRUG	Sodium chloride 0.9%	100 ml sodium chloride 0.9% will be administered in a time frame of 15-30 minutes

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-09-01
• Completion: 2025-09-01
• First posted: 2022-07-19
• Last updated: 2022-07-19