NCT06414031

Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery

Tranexamic Acid for Reduction of Intra- and Postoperative Transfusion Requirements in Elective Abdominal Surgery: Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 850 (estimated)
• Sponsor: Ulrich Ronellenfitsch, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if the administration of tranexamic acid can reduce the necessity of blood transfusions in adult patients undergoing major abdominal surgery. . It will also inform about safety of tranexamic acid in this setting. The main question it aims to answer is: Does tranexamic acid lower the probability of receiving at least one blood transfusion during or after surgery? Participants will compare tranexamic acid o a placebo (a look-alike substance that contains no drug) to see if tranexamic acid works to reduce the necessity of a blood transfusion.

Conditions

• Surgical Blood Loss
• Transfusion-dependent Anemia
• Abdomen Disease

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Intravenous administration
DRUG	Placebo	Intravenous administration

Timeline

• Start date: 2024-06-17
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2024-05-14
• Last updated: 2024-10-15

Locations

2 sites across 1 country: Germany