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

Phase 3TerminatedNCT03954314

Population Health Research Institute3,242 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

3,242

Conditions

Bleeding Surgical Blood Loss Seizures

Interventions

Tranexamic AcidDRUG

Tranexamic Acid is a medication used to treat or prevent excessive blood loss from major trauma, post partum, surgery, tooth removal, nose bleeds, and heavy menstruation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

Kelowna General Hospital

Kelowna, British Columbia, Canada

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Outcomes

Primary Outcomes

The proportion of patients experiencing an in-hospital seizure

To determine in patients undergoing on-pump cardiac surgery, if topical tranexamic acid (intra-pericardial) is superior to the usual intravenous tranexamic acid administration for reducing the risk of in-hospital seizure.

Time frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)

Secondary Outcomes

The proportion of patients in-hospital who receive red blood cell transfusions

To determine in patients undergoing on-pump cardiac surgery, if topical tranexamic acid (intra-pericardial) compared with intravenous tranexamic acid administration is associated with a non-inferior risk of in-hospital red blood cell transfusion.

Time frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)

Data from ClinicalTrials.gov

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