Actively Recruiting
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
Eligibility Criteria
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
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
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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