Peroperative Administration of Tranexamic acid in gastric bypass to reduce haemorrhage in patients with morbid obesity

Phase 1

• Conditions: Morbid obesity; MedDRA version: 21.1Level: LLTClassification code: 10068900Term: Bariatric surgery Class: 10042613; MedDRA version: 21.0Level: LLTClassification code: 10027966Term: Morbid obesity Class: 10027433; MedDRA version: 21.1Level: LLTClassification code: 10059610Term: Obesity surgery Class: 10042613; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2024-513570-22-00
• Lead Sponsor: Sint Franciscus Vlietland Groep Stichting

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1524

Inclusion Criteria

Patients aged 18 years or older, eligible for bariatric surgery according to the IFSO guidelines and undergoing a laparoscopic (Roux-en-Y or one-anastomosis) gastric bypass.

Exclusion Criteria

Patients unwilling to give informed consent, patients with a medical history of bleeding or venous thromboembolism and patients that use anticoagulants will be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified