Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid 2 Pilot Trial

Launched by HAMILTON HEALTH SCIENCES CORPORATION · Sep 30, 2024

Keywords

ClinConnect Summary

The clinical trial titled "Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid 2 Pilot Trial" is designed to explore the best timing for giving a medication called tranexamic acid during heart surgery. This medication is used to help reduce blood loss and prevent complications like seizures. The researchers want to find out if it's possible to conduct a larger study in the future and to measure how much of the medication is in the blood after it's given either before or after a specific part of the surgery called cardiopulmonary bypass.

To participate in this trial, individuals must be at least 18 years old and scheduled for certain types of heart surgery that involve cardiopulmonary bypass. Participants will need to give their consent and will receive tranexamic acid during their surgery. They will also provide blood samples at several times to help researchers understand how the medication works in the body. However, some people may not be eligible to join, such as those with allergies to the medication or specific health conditions. Overall, this trial is an important step in improving care for patients undergoing heart surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ≥18 years of age
• • 2. Undergoing a cardiac surgical procedure (i.e., isolated CABG, isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass
• • 3. Provide written informed consent
• Exclusion Criteria:
• • 1. Allergy to tranexamic acid
• 2. Fulfill any of the following transfusion risk factors (A-F):
• • A. Emergency surgery B. History of bleeding disorder C. Inherited thromboembolic or hemorrhagic disease D. Infective endocarditis (active) E. Pre-operative thrombocytopenia (\<50,000 platelets per µL) F. Pre-operative hemoglobin \<110 g/L
• • 3. Estimated glomerular filtration rate \<30 mL/min (CKD-EPI equation) or on dialysis
• • 4. Pre-operative hemoglobin \>170 g/L
• • 5. Expected circulatory arrest
• • 6. Pregnancy or breast feeding
• • 7. Previous enrollment in DEPOSITION trial
• • 8. Refusal of blood products (e.g., Jehovah's Witnesses)
• • 9. Isolated Pericardiectomy