Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery (NCT06414031) | Clinical Trial Compass
RecruitingPhase 3
Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery
Germany850 participantsStarted 2024-06-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Adequate renal function with serum creatinine \<250 µmol/L (2.82 mg/dL)
✓. Written informed consent obtained before randomization
✓. Negative pregnancy test for women of childbearing potential within 14 days of commencing study treatment. Females of reproductive potential must agree to practice highly effective contraceptive measures during the study. These comprise measures with a failure rate of \<1% per year when used consistently and correctly, such as intravaginal and transdermal combined (oestrogen and progestogen containing) hormonal contraception, injectable and implantable progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion; vasectomised partner, sexual abstinence (defined as refraining from heterosexual intercourse during the entire study period).
Exclusion criteria
✕. Severe anaemia, defined as a haemoglobin concentration \<8 g/dL (\<5 mmol/L) or anaemia with haemoglobin concentration ≥8 to \<10 g/dL (≥5,0 to \<6,2 mmol/l) and one or several of the following symptoms suggesting hypoxemia:
What they're measuring
1
Transfusion necessity
Timeframe: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
✕. Thrombocytopenia with platelets \<60 x 109 /L
✕. Confirmed bleeding disorder with the need for specific preventive perioperative treatment (e.g., factor deficiency with the need of perioperative substitution)
✕. A priori refusal of blood transfusions
✕. Confirmed thrombophilia with a pertinent need for perioperative anticoagulation
✕. Allergy / hypersensitivity to tranexamic acid