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
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Hemorrhage
• Heparin
• Surgery, Cardiac

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