Actively Recruiting
Comparative Study of Tranexamic Acid Dosage Regimens in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass
Led by University of Ioannina · Updated on 2025-09-10
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying different dosages of tranexamic acid in adults undergoing elective cardiac surgery with cardiopulmonary bypass to understand how long the drug inhibits fibrinolysis, which helps prevent excessive bleeding. This trial aims to find the best dosage regimen by measuring clotting function and drug levels in the blood. The study is randomized and quadruple-masked to compare three dosing strategies and their impact on blood loss and related complications. Participants will be randomly assigned to one of three groups receiving tranexamic acid: a 10 mg/kg dose followed by a continuous infusion of 1 mg/kg per hour until surgery ends, a single 20 mg/kg dose, or a single 30 mg/kg dose given before surgery starts. Blood samples will be collected at multiple time points during and after surgery to perform ClotPro viscoelastic testing and measure tranexamic acid levels. If clotting inhibition decreases early, an additional 10 mg/kg dose is given. Throughout the study, researchers will collect detailed information including patient characteristics, surgery duration, anesthesia details, blood transfusions, bleeding amounts, and any adverse events. Postoperative care data such as mechanical ventilation duration, ICU and hospital stays, and mortality will also be tracked. The primary measurement is the duration of fibrinolysis inhibition as indicated by ClotPro results and its correlation with tranexamic acid blood levels. Secondary outcomes include bleeding, transfusion needs, seizures, thrombotic events, and length of recovery up to one year after surgery.
CONDITIONS
Brief Title
Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing elective cardiac surgery using cardiopulmonary bypass
- Patients to have discontinued anticoagulant and antiplatelet therapy preoperatively according to guidelines
- Adults aged 18 to 99 years
You will not qualify if you...
- Age below 18 years
- Patient refusal
- Pregnancy
- End-stage renal disease
- History of epilepsy
- Cardiac surgery without the use of cardiopulmonary bypass (off-pump)
- Emergency operations
- Known allergy to the administered agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Duration of surgery
Participants undergo cardiac surgery using cardiopulmonary bypass and receive one of three dosage regimens of tranexamic acid after anesthesia induction to reduce bleeding.
1 surgery day visit (in-person)
Duration - Up to 1 year after surgery
Participants are monitored postoperatively in the ICU and hospital for bleeding, transfusions, complications, mechanical ventilation duration, and recovery until hospital discharge.
Visits during ICU stay and hospital stay; follow-ups may continue up to 1 year
Trial Site Locations
Total: 1 location
1
University Hospital of Ioannina
Ioannina, Greece
Actively Recruiting
Research Team
E
Evangelia Samara
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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