Activated Clotting Time, Cardiopulmonary Bypass, Heparin, Surgery, Cardiac, Tranxemic Acid
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGTranexamic acid
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.
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | 24 hours | monitor the amount of blood loss after procedure |
| blood transfusion | procedure time, an average of 6 hours | the amount of blood transfusion during procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day mortality | 30 days | 30-day mortality after procedure |
Countries
Taiwan
Contacts
Primary ContactYung-Szu Wu, MD
Backup ContactYi-Ting Chang, MD
Outcome results
None listed