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

Study Overview
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Brief Summary
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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: Does higher dose of tranexamic acid reduce the amount of bleeding and blood transfusion? 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.

Detailed Description
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This study is going to analyze the medical records of patients who underwent cardiac surgery between December 1, 2023, and December 31, 2026. The investigators will categorize patients into four groups based on anticoagulation indices (ACT 400-600 seconds; ACT > 600 seconds) and tranexamic acid dosages (low dose; high dose) within the range considered safe for CPB. The primary outcome will be the volume of postoperative bleeding within 24 hours for each group. The findings of this study will contribute to the existing clinical evidence and provide insights for the monitoring and pharmacological management in cardiac surgery.

Official Title
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The Dose Effect of Activated Clotting Time and Tranexamic Acid on Bleeding in Adult Cardiac Surgery

Conditions
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Tranxemic Acid, Surgery, Cardiac, Activated Clotting Time, Heparin, Cardiopulmonary Bypass

Intervention / Treatment
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* Drug: Tranexamic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult, cardiac surgery with cardiopulmonary bypass Exclusion Criteria: pregnant emergency procedure immune compromised aortic surgery end-stage renal disease liver disease critical status incomplete clinical data

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: During cardiac surgery with cardiopulmonary bypass support, participants will be divided into 4 groups. During procedure, they will recieve different doses of tranexamic acid and different level of activated clotting time. Then, we will monitor the amount of blood loss and blood transfusion.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose tranexamic acid + high ACT level<br>high dose tranexamic acid: 50mg/kg ACT level: > 600 sec | Drug: Tranexamic acid<br>* 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.<br>|
| Active Comparator: High dose tranexamic acid + low ACT level<br>high dose tranexamic acid: 50mg/kg ACT level: 400  600 sec | Drug: Tranexamic acid<br>* 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.<br>|
| Active Comparator: Low dose tranexamic acid + low ACT level<br>Low dose tranxeamic acid: 20mg/kg ACT level: 400  600 sec | Drug: Tranexamic acid<br>* 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.<br>|
| Placebo Comparator: Low dose tranexamic acid + high ACT level<br>Low dose tranxeamic acid: 20mg/kg ACT level: > 600 sec | Drug: Tranexamic acid<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | monitor the amount of blood loss after procedure | 24 hours | 
| blood transfusion | the amount of blood transfusion during procedure | procedure time, an average of 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | 30-day mortality after procedure | 30 days |