DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim is to conduct a double-dummy multi-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TxA) versus the usual intravenous TxA in patients undergoing on-pump cardiac surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

1. ≥ 18 years of age

2. 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

3. Provide written informed consent

Exclusion Criteria:

1. Allergy to tranexamic acid

2. Undergoing minimally invasive surgery

3. 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

4. History of previous cardiac surgery

5. Severe renal impairment (serum creatinine >250 µmol/L)

6. Pre-operative hemoglobin <120 g/L

7. Pre-operative thrombocytopenia (<50,000 platelets per µL)

8. Expected circulatory arrest

9. Pregnancy or breast feeding

10. Previously enrolled in the DEPOSITION trial