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

Phase 4

Completed

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
TA Topical	Tranexamic Acid	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.
TA Intravenous	Tranexamic Acid	2 syringes of 50ml (5mg) Tranexamic Acid for intravenous injection or placebo.

Primary Outcome Measures

Name	Time	Method
Median Volume of Mediastinal Fluid Collected From Participants	Fluid collected in the first 24 hours after the surgical procedure	Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Mortality	Patients will be followed post-operatively until hospital discharge	The occurrence of death due to any cause
Number of Participants With Re-operation for Bleeding or Tamponade	Patients will be followed post-operatively until hospital discharge	Occurrence of re-operation for the purpose of bleeding or cardiac tamponade
Median Number of Hours Participants Spent in ICU	Number of hours spent in ICU from arrival to exit (collected at the Post-Operative Visit).	Number of hours participants spent in the intensive care unit (ICU)
Mean Concentration of TxA in Plasma Collected From Participants	on arrival in ICU within 3 hours	Plasma TxA concentrations measured from blood samples taken upon arrival in the ICU
Number of Participants With Seizures	Patients will be followed post-operatively until hospital discharge	Patients experiencing a post-operative seizure
Number of Participants With RBC Transfusion	Intra-operative and post-operative RBC transfusions	Patients requiring a red blood cell transfusion