A Randomized Comparison of Two Doses of Tranexamic Acid in Open-Heart Surgery
Status:
Not yet recruiting
Trial end date:
2022-01-30
Target enrollment:
Participant gender:
Summary
Perioperative bleeding during cardiac surgery is associated with a higher incidence of
reoperation and blood transfusion leading to an increase in morbidity and mortality.
Coagulopathy is a major cause of excessive bleeding. It is associated with use of
cardiopulmonary bypass which activates the intrinsic and extrinsic coagulation pathway,
platelet dysfunction and systemic inflammatory response. Increase in duration of
cardiopulmonary bypass correlates directly with increase bleeding during cardiac surgery.
Antifibrinolytic agents like tranexamic acid has shown promising result in major surgeries
and in trauma patients. Current clinical practice guidelines recommended use of tranexamic
acid in cardiac surgery. There are wide variations in dose of tranexamic acid ranging from
10mg/Kg to 100mg/kg. The higher dose of this drug is associated with seizures and
thromboembolic events including stroke. The objective is to find out the minimal effective
dose of tranexamic acid in open-heart surgery.
This is a prospective comparative study among the patients undergoing open heart surgery in
Shahid Gangalal National Heart Center, Kathmandu Nepal. The inclusion criteria include
patients with age more than 18years, surgery with total cross clamp time more than 60 min.
The exclusion criteria are the patients with allergy to tranexamic acid or any of the lysine
analogues, history of seizure, chronic homeostasis abnormality, on anticoagulants, severe
chronic kidney disease with creatinine clearance less than 30ml/hr, deranged liver function
test, total cross clamp time less than 60 min. The sample size was calculated to be 100
including 10% dropout cases. Patients will be randomized into two groups Group H (High dose
group) and Group L (Low dose group) with a sealed envelope technique. Low-dose TEA consists
of 10 mg/kg bolus administration before incision, followed by1 mg/kg/hr infusion; High-dose
TEA consists of a 30 mg/kg bolus followed by a 1mg/kg/hr infusion till the end of surgery.
Blood sampling and transfusion will be done as per protocol of Shahid Gangalal National Heart
Center. The primary study endpoint was the amount of blood loss during the first 24 hours
after surgery. The secondary endpoint was the incidence of overall blood transfusion and
hemoglobin concentration on the first postoperative day after surgery. All adverse effects of
the drug were noted and were treated as per hospital protocol. Data will be collected using
the data collection form (proforma). Collected data will be analyzed by means of spss version
20 for windows. The result will be presented as mean ± SD. The continuous variable will be
compared between the two groups by student t test and categorical variables with the
chi-square test. A minimum level of significance is maintained at the p-value of <0.05.