Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Ioannina

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing elective cardiac surgery using cardiopulmonary bypass

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

Disqualifiers

Age below 18 years

Patient refusal

Pregnancy

End-stage renal disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Tranexamic acid at a dose of 20 mg/kg

    Drug

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

  • Tranexamic acid at a dose of 30 mg/kg

    Drug

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

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 frame
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.
2

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 frame
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

1

transfusion of blood and products

Patient's transfusion requirements for packed red blood cell units, fresh frozen plasma units and platelets units.

Time frame
Ιntraoperatively and during the first 24 hours postoperatively
2

need of administration of coagulation factors

Need for administration of coagulation factors such as fibrinogen (gr), prothrombin complex concentrate, PCC (IU) and calcium (gr)

Time frame
intraoperatively and during the first 24 hours postoperatively
3

Postoperative bleeding

The total amount of blood present in the drainage tube in ml.

Time frame
During the first 24 hours postoperatively
4

reoperation

The need for reoperation due to postoperative bleeding

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

Other outcomes

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