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

Population Health Research Institute97 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Bleeding Surgical Blood Loss

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: * 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 )

Locations (1)

Hamilton General Hospital

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Median Volume of Mediastinal Fluid Collected From Participants

Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure

Time frame: Fluid collected in the first 24 hours after the surgical procedure

Secondary Outcomes

Number of Participants With Seizures

Patients experiencing a post-operative seizure

Time frame: Patients will be followed post-operatively until hospital discharge

Number of Participants With Mortality

The occurrence of death due to any cause

Time frame: Patients will be followed post-operatively until hospital discharge

Number of Participants With RBC Transfusion

Patients requiring a red blood cell transfusion

Time frame: 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

Time frame: 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)

Time frame: 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

Data from ClinicalTrials.gov

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