Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery

NCT07164300 | Recruiting

• 1 other identifier: 886/11-11-2024
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• duration of inhibition of fibrinolysis as measured by the ClotPro-TPA test

  time(hours) from tranexamic acid administration until the values of ML and LT in the TPA test (Clot Pro) become greater than 50% and less than 2100 sec, respectively (0,3,6,12,24,36,48 etc up to 240 hours post tranexamic acid bolus administration).

  time(hours) from tranexamic acid administration until the values of ML and LT in the TPA test (Clot Pro) become greater than 50% and less than 2100 sec, respectively,up to 240 hours post tranexamic acid bolus administration.

• tranexamic blood concentration

  Blood concentration of tranexamic acid at predifined study time points (0,3,6,12,24,36,48 etc up to 240 hours post tranexamic acid bolus administration)

  time(hours) from tranexamic acid administration until the values of ML and LT in the TPA test (Clot Pro) become greater than 50% and less than 2100 sec, respectively, and up to up to 240 hours post tranexamic acid bolus administration.

Secondary Outcomes (10)

• transfusion of blood and products

  Ιntraoperatively and during the first 24 hours postoperatively

• need of administration of coagulation factors

  intraoperatively and during the first 24 hours postoperatively

• Postoperative bleeding

  During the first 24 hours postoperatively

• reoperation

  From the end of surgery until the patient's discharge from the hospital or death (up to 1 year)

• Mechanical ventilation

  From the end of surgery until the patient's extubation, or patient's death if not extubated. (up to 1 year)

Study Arms (3)

Group 1

EXPERIMENTAL

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.

Drug: Tranexamic acid at a dose of 10 mg/kg followed by 1 mg/kg/h

Group 2

EXPERIMENTAL

Group 2 will receive a tranexamic acid dosage of 20mg/kg prior to operation start.

Drug: Tranexamic acid at a dose of 20 mg/kg

Group 3

EXPERIMENTAL

Group 3 will receive a tranexamic acid dosage of 30mg/kg prior to operation start.

Drug: Tranexamic acid at a dose of 30 mg/kg

Interventions

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

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

Also known as: Group 1

Group 1

Tranexamic acid at a dose of 20 mg/kg DRUG

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

Also known as: Group 2

Group 2

Tranexamic acid at a dose of 30 mg/kg DRUG

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

Also known as: Group 3

Group 3

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

University Hospital of Ioannina

Ioannina, Greece

RECRUITING

MeSH Terms

Conditions

Blood Coagulation Disorders; Postoperative Hemorrhage; Drug-Related Side Effects and Adverse Reactions; Hemorrhage

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Chemically-Induced Disorders

Study Officials

• Evangelia Samara

  University of Ioannina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evangelia Samara

CONTACT

6972325749; gelysamara@uoi.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anaesthesiology

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: September 10, 2025
• Study Start: May 14, 2024
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)