RecruitingNot ApplicableNCT07164300

Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery

Comparative Study of Tranexamic Acid Dosage Regimens in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass

Sponsor

University of Ioannina

Enrollment

150 participants

Start Date

May 14, 2024

Study Type

INTERVENTIONAL

Conditions

Adverse Drug Event Fibrinolysis; Hemorrhage Blood Coagulation Disorder Postoperative Blood Loss Tranexamic Acid Adverse Reaction

Summary

Tranexamic axid is routinely used as an antifibrinolytic agent in cardiac surgery to reduce the risk of blood loss and transfusion. However, there is no consensus regarding the dosage regimen of tranexamic acid that should be administered. The purpose of this study is to compare different dosages of tranexamic acid in cardiac surgery using cardiopulmonary bypass regarding the duration of inhibition of fibrinolysis as measured by the ClotPro test. Blood samples will be taken from the arterial line placed in the patient at specified time points in order to perform viscoelastic tests (ClotPro, TPA test), to detect successful inhibition of fibrinolysis and to measure tranexamic acid levels in the patient's blood. In case the action of tranexamic acid stops early postoperatively an additional dose of the medication will be administered to the patient.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria2

Patients undergoing elective cardiac surgery using cardiopulmonary bypass
Patients to have discontinued anticoagulant and antiplatelet therapy preoperatively according to guidelines.

Exclusion Criteria8

Age below 18 years
Patient refusal
Pregnancy
End-stage renal disease
History of epilepsy,
Cardiac surgery without the use of cardiopulmonary bypass (off-pump)
Emergency operations
Known allergy to the administered agents.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTranexamic acid at a dose of 10 mg/kg followed by 1 mg/kg/h

Group 1: administration of tranexamic acid at a dose of 10 mg/kg followed by 1 mg/kg/h

DRUGTranexamic acid at a dose of 20 mg/kg

Group 2: administration of tranexamic acid at a dose of 20 mg/kg

DRUGTranexamic acid at a dose of 30 mg/kg

Group 3: administration of tranexamic acid at a dose of 30 mg/kg

Locations(1)

University Hospital of Ioannina

Ioannina, Greece

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07164300

Related Trials

Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia

NCT055121692 locations

Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients

NCT065755301 location