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

Phase 4

Recruiting

• Conditions: Surgery, Cardiac; Tranxemic Acid; Activated Clotting Time; Heparin; Cardiopulmonary Bypass
• Interventions: Drug: Tranexamic acid

• Registration Number: NCT06109155
• Lead Sponsor: Taichung Veterans General Hospital

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.

Study Timeline

• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-10-31
• Status Verified: 2024-02
• Study Start: 2024-02-08
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose tranexamic acid + low ACT level	Tranexamic acid	high dose tranexamic acid: 50mg/kg ACT level: 400\~ 600 sec
Low dose tranexamic acid + low ACT level	Tranexamic acid	Low dose tranxeamic acid: 20mg/kg ACT level: 400\~ 600 sec
High dose tranexamic acid + high ACT level	Tranexamic acid	high dose tranexamic acid: 50mg/kg ACT level: \> 600 sec
Low dose tranexamic acid + high ACT level	Tranexamic acid	Low dose tranxeamic acid: 20mg/kg ACT level: \> 600 sec

Primary Outcome Measures

Name	Time	Method
blood transfusion	procedure time, an average of 6 hours	the amount of blood transfusion during procedure
Blood loss	24 hours	monitor the amount of blood loss after procedure

Secondary Outcome Measures

Name	Time	Method
30-day mortality	30 days	30-day mortality after procedure

Trial Locations

Locations (2)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Taichung Veterans General hospital; 🇨🇳 Taichung, Taiwan