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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose tranexamic acid + high ACT level | Active Comparator | high dose tranexamic acid: 50mg/kg ACT level: > 600 sec |
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| High dose tranexamic acid + low ACT level | Active Comparator | high dose tranexamic acid: 50mg/kg ACT level: 400~ 600 sec |
|
| Low dose tranexamic acid + low ACT level | Active Comparator | Low dose tranxeamic acid: 20mg/kg ACT level: 400~ 600 sec |
|
| Low dose tranexamic acid + high ACT level | Placebo Comparator | Low dose tranxeamic acid: 20mg/kg ACT level: > 600 sec |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality | 30-day mortality after procedure | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yung-Szu Wu, MD | Contact | 0423592525 | 5063 | adconvert98@gmail.com |
| Yi-Ting Chang, MD | Contact | 04-23592525 | 5062 | alisonytchang@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital | Recruiting | Taichung | 40705 | Taiwan |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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.
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In the research process, any raw data will be kept and encrypted by the principal investigator, and it will not be accessible or interpretable by others.
| Taichung Veterans General hospital | Recruiting | Taichung | 40705 | Taiwan |
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