NCT06109155

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Taichung Veterans General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgery, Cardiac
• Tranxemic Acid
• Activated Clotting Time
• Heparin
• Cardiopulmonary Bypass

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-08
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-10-31
• Last updated: 2024-02-21

Locations

2 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study