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

Population Health Research Institute (PHRI)

Status and phase: Completed; Phase 4

Conditions: Surgical Blood Loss; Bleeding

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03376061

DEPOSITION 1.0 2017-07-28

Details and patient eligibility

About

The aim is to conduct a double-blinded single-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TA) versus the usual intravenous TA in patients undergoing cardiac surgery at the Hamilton General Hospital. This pilot study will assess the feasibility to perform a large randomized international trial exploring this objective.

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 (TA) has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements. Although intravenous TA is usually well tolerated, there is a well-known risk (1 to 4%) of postoperative seizures. This is due to the similarity between TA and the brain tissues. The aim is to eliminate the risk of seizures but to maintain the protection against bleeding. When TA is used directly on the tissues (topically) for other type of surgeries (joints), TA is effective to reduce blood loss and transfusions. The aim is to prove that direct application of TA on the heart can eliminate postoperative seizures and reduce the amount of blood transfusions in patients who have cardiac surgery.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female >= 18 years old
• Undergoing cardiac surgical procedure with the use of cardiopulmonary bypass and median sternotomy
• Provide written informed consent

Exclusion criteria

• Poor (English) language comprehension
• Minimally invasive valve surgery
• Off-pump procedures
• Emergency operations
• Known history of increased bleeding disorder
• Thromboembolic disease
• Allergy to tranexamic acid
• Severe renal impairment (eGFR <30 mL/min/1.73m2 )

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 2 patient groups

TA Topical

Active Comparator group

Description:

1 syringe of 50ml of topical Tranexamic Acid (5g) or placebo. The topical will be poured into the pericardial mediastinal cavities in 2 equal doses, 25ml when the pt comes off-pump and the other 25ml before sternotomy is closed.

Treatment:

Drug: Tranexamic Acid

TA Intravenous

Active Comparator group

Description:

2 syringes of 50ml (5mg) Tranexamic Acid for intravenous injection or placebo.

Treatment:

Drug: Tranexamic Acid