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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Patients undergoing elective cardiac surgery using cardiopulmonary bypass

• Patients to have discontinued anticoagulant and antiplatelet therapy preoperatively according to guidelines.

Locations
Other Locations
Greece
University Hospital of Ioannina
RECRUITING
Ioannina
Contact Information
Primary
Evangelia Samara
gelysamara@uoi.gr
6972325749
Time Frame
Start Date: 2024-05-14
Estimated Completion Date: 2027-12-15
Participants
Target number of participants: 150
Treatments
Experimental: Group 1
Group 1 will receive a tranexamic acid dosage of 10mg/kg prior to operation start, followed by transfusion rate of 1mg/kg/h until the end of the surgery.
Experimental: Group 2
Group 2 will receive a tranexamic acid dosage of 20mg/kg prior to operation start.
Experimental: Group 3
Group 3 will receive a tranexamic acid dosage of 30mg/kg prior to operation start.
Related Therapeutic Areas
Sponsors
Leads: University of Ioannina

This content was sourced from clinicaltrials.gov