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

Population Health Research Institute (PHRI)

Status and phase: Terminated; Phase 3

Conditions: Seizures; Surgical Blood Loss; Bleeding

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03954314

DEPOSITION

Details and patient eligibility

About

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.

Full description

Postoperative bleeding related to open cardiac surgery increases the rates of complications and mortality. It results from the blood thinners that are needed for use. Intravenous tranexamic acid (TxA) has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements. Although intravenous TxA is usually well tolerated, there is a well-known risk (1 to 4%) of postoperative seizures. This is due to the similarity between TxA and the brain tissues. The aim is to eliminate the risk of seizures but to maintain the protection against bleeding. When TxA is used directly on the tissues (topically) for other type of surgeries (joints), TxA is effective to reduce blood loss and transfusions. The aim is to prove that direct application of TxA on the heart can eliminate postoperative seizures and reduce the amount of blood transfusions in patients who have cardiac surgery.

Enrollment: 3,242 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 (active)

4. History of previous cardiac surgery

5. Estimated glomerular filtration rate <30 mL/min (CKD-EPI equation) or on dialysis

6. Pre-operative hemoglobin > 170 g/L or <110 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

11. Refusal of blood products

12. Pericardiectomy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,242 participants in 2 patient groups

Topical Tranexamic Acid/Placebo

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic Acid

Intravenous Tranexamic Acid/Placebo

Active Comparator group

Description:

Intravenous Tranexamic Acid 1 to 10g (10 to 100mL) or placebo administered intravenously at the induction of anesthesia as a bolus-infusion.

Treatment:

Drug: Tranexamic Acid