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The Effect of ACT and Tranexamic Acid on Bleeding in Cardiac Surgery

ConditionsSurgery, CardiacTranxemic AcidActivated Clotting TimeHeparinCardiopulmonary Bypass
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaichung Veterans General Hospital

About this trial

The goal of this clinical trial is to the dose effect of tranexamic acid and the level of ACT on bleeding in adult cardiac surgery.

The main questions it aims to answer are:

1. Does higher dose of tranexamic acid reduce the amount of bleeding and blood transfusion? 2. Does lower ACT level during cardiac surgery reduce the amount of bleeding and blood transfusion?

Participants will divided into four groups which have different tranexamic acid dose and ACT level during cardiac surgery to see if there is any different in the amount of bleeding and blood transfusion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult, cardiac surgery with cardiopulmonary bypass

Disqualifiers

pregnant

emergency procedure

immune compromised

aortic surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tranexamic acid

    Drug

    tranexamic acid will be used in two different doses (50mg/kg vs 20mg/kg). the tranexamic acid pump will start from the begin of anesthesia until all dose is administrated.

Treatment groups

150 Participants
are divided into 4 treatment groups
Group A: High dose tranexamic acid + high ACT levelActive comparator 1 intervention
Group B: High dose tranexamic acid + low ACT levelActive comparator 1 intervention
Group C: Low dose tranexamic acid + low ACT levelActive comparator 1 intervention
Group D: Low dose tranexamic acid + high ACT levelPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Blood loss

monitor the amount of blood loss after procedure

Time frame
24 hours
2

blood transfusion

the amount of blood transfusion during procedure

Time frame
procedure time, an average of 6 hours

Secondary outcomes

1

30-day mortality

30-day mortality after procedure

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taichung Veterans General Hospital

Lead sponsor

Source ClinicalTrials.gov
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