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NCT06109155 Clinical Trial

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

Cardiopulmonary Bypass Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06109155
Other study ID # CF23323A
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date February 8, 2024
Est. completion date December 31, 2026

Study information
Verified date February 2024
Source Taichung Veterans General Hospital
Contact Yung-Szu Wu, MD
Phone 0423592525
Email adconvert98@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tranexamic 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.

Locations
Country Name City State
Taiwan Taichung Veterans General Hospital Taichung
Taiwan Taichung Veterans General hospital Taichung

Sponsors (1)
Lead Sponsor Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood loss monitor the amount of blood loss after procedure 24 hours
Primary blood transfusion the amount of blood transfusion during procedure procedure time, an average of 6 hours
Secondary 30-day mortality 30-day mortality after procedure 30 days
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