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

Study Overview
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Brief Summary
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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
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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.

Official Title
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DEPOSITION: Pilot Study Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery

Conditions
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Bleeding, Surgical Blood Loss

Intervention / Treatment
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* Drug: Tranexamic Acid


Participation Criteria
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Eligibility Criteria
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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 )

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Tranexamic Acid intravenous + Placebo topical versus Placebo intravenous + Tranexamic Acid topical
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TA Topical<br>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. | Drug: Tranexamic Acid<br>* 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.<br>* Other names: Cyklokapron;|
| Active Comparator: TA Intravenous<br>2 syringes of 50ml (5mg) Tranexamic Acid for intravenous injection or placebo. | Drug: Tranexamic Acid<br>* 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.<br>* Other names: Cyklokapron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Volume of Mediastinal Fluid Collected From Participants | Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure | Fluid collected in the first 24 hours after the surgical procedure | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic Acid, Cardiac surgery