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Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery

NCT07164300 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Tranexamic 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

DRUG

Tranexamic acid at a dose of 20 mg/kg

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

DRUG

Tranexamic acid at a dose of 30 mg/kg

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

Sponsors & Collaborators

  • University of Ioannina

    lead OTHER

Principal Investigators

  • Evangelia Samara · University of Ioannina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-14
Primary Completion
2027-12-15
Completion
2027-12-15

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07164300 on ClinicalTrials.gov