Measuring the effects of Tranexamic Acid during heart surgery
Point-of-care Measurement of the Antifibrinolytic Activity of Tranexamic Acid in Cardiac Surgery
This study tests different doses of Tranexamic Acid during heart surgery to see if it can help reduce blood loss and the need for blood transfusions.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 322 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT06128330 on ClinicalTrials.gov |
What this trial studies
This study evaluates the antifibrinolytic activity of Tranexamic Acid (TXA) during cardiac surgery using a new point-of-care diagnostic assay. The trial aims to determine the optimal dosing of TXA to minimize postoperative blood loss and reduce the need for blood transfusions. Patients undergoing elective cardiac procedures such as aortocoronary artery bypass graft surgery or valve replacements will receive varying doses of TXA, allowing for real-time adjustments based on the assay results. The study seeks to establish a standardized approach to TXA administration in the operating room.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for elective cardiac surgeries like aortocoronary artery bypass grafting or valve replacements with normal renal function.
Not a fit: Patients with impaired renal function, a history of seizures, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood management and reduced complications for patients undergoing cardiac surgery.
How similar studies have performed: Previous studies have shown positive outcomes with TXA in reducing blood loss during cardiac surgery, supporting the potential success of this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Eligible patients: * Over 18 years old * Elective surgery * Written informed consent * Patient planned for aortocoronary artery bypass graft surgery, aortic valve replacement or mitral valve surgery (or a combination of these procedures) * Normal renal function * No previous intake of anticoagulants except acetylsalicylic acid in the preoperative period Exclusion Criteria: * Impaired renal function (eGFR \< 30 ml/min.) * History of seizure * Pregnancy * Inability to understand and sign the informed consent (e.g., language problems, dementia, psychological disorders)
Where this trial is running
Bern
- Dpt. Anesthesiology and pain Medicine — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Annegret Kauert-Willms, MD — University Hospital Berne
- Study coordinator: Gabor Erdoes, MD
- Email: Gabor.erdoes@insel.ch
- Phone: ++41 31 632 2726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.