DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery (DEPOSITION)
Bleeding, Surgical Blood Loss, Seizures
About this trial
This is an interventional prevention trial for Bleeding focused on measuring Tranexamic Acid, On-pump Cardiac Surgery
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years of age
- Undergoing a cardiac surgical procedure (i.e. isolated coronary artery bypass graft (CABG), isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass (CPB) and median sternotomy
- Provide written informed consent
Exclusion Criteria:
- Allergy to tranexamic acid
- Undergoing minimally invasive surgery
Fulfill any of the following transfusion risk factors (A-D):
A. Emergency surgery B. History of bleeding disorder C. Inherited thromboembolic or hemorrhagic disease D. Infective endocarditis (active)
- History of previous cardiac surgery
- Estimated glomerular filtration rate <30 mL/min (CKD-EPI equation) or on dialysis
- Pre-operative hemoglobin > 170 g/L or <110 g/L
- Pre-operative thrombocytopenia (<50,000 platelets per µL)
- Expected circulatory arrest
- Pregnancy or breast feeding
- Previously enrolled in the DEPOSITION trial
- Refusal of blood products
- Pericardiectomy
Sites / Locations
- Kelowna General HospitalRecruiting
- St. Boniface HospitalRecruiting
- Saint John Regional HospitalRecruiting
- Hamilton Health Sciences - General HospitalRecruiting
- CHUMRecruiting
- Montreal Heart InstituteRecruiting
- IUCPQRecruiting
- Petrovsky National Research CentreRecruiting
- E.Meshalkin National Medical Research CenterRecruiting
- Saint-Petersburg State University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Topical Tranexamic Acid/Placebo
Intravenous Tranexamic Acid/Placebo
Topical Tranexamic Acid 5g to 10g (50 to 100mL) or placebo. The topical will be poured into the pericardial and mediastinal cavities after protamine administration.
Intravenous Tranexamic Acid 1 to 10g (10 to 100mL) or placebo administered intravenously at the induction of anesthesia as a bolus-infusion.