Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06414031

Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery

Led by Ulrich Ronellenfitsch, MD · Updated on 2026-04-29

850

Participants Needed

2

Research Sites

128 weeks

Total Duration

On this page

Sponsors

U

Ulrich Ronellenfitsch, MD

Lead Sponsor

G

German Federal Ministry of Education and Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or above
  • Planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy
  • Adequate renal function with serum creatinine <250 �b5mol/L (2.82 mg/dL)
  • Written informed consent obtained before randomization
  • Negative pregnancy test for women of childbearing potential within 14 days of starting study treatment
  • Females of reproductive potential must agree to use highly effective contraception during the study
Not Eligible

You will not qualify if you...

  • Severe anaemia with hemoglobin <8 g/dL or hemoglobin 8 to <10 g/dL with symptoms of low oxygen levels such as fast heart rate, low blood pressure, or breathing difficulties
  • Platelet count below 60 x 10^9/L
  • Confirmed bleeding disorder requiring special preventive treatment during surgery
  • Refusal of blood transfusions
  • Confirmed thrombophilia needing perioperative blood thinning treatment
  • Allergy or hypersensitivity to tranexamic acid
  • Thromboembolic event within the past 30 days
  • History of medically confirmed seizures
  • Pregnancy or breastfeeding in female participants

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University Hospital Carl Gustav Carus Dresden

Dresden, Saxony, Germany, 01307

Actively Recruiting

2

University Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery

Halle, Germany, 06120

Actively Recruiting

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Research Team

U

Ulrich Ronellenfitsch, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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