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

Taichung Veterans General Hospital

Status and phase: Enrolling; Phase 4

Conditions: Heparin; Surgery, Cardiac; Cardiopulmonary Bypass; Tranxemic Acid; Activated Clotting Time

Treatments: Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06109155

CF23323A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 4 patient groups, including a placebo group

High dose tranexamic acid + high ACT level

Active Comparator group

Description:

high dose tranexamic acid: 50mg/kg ACT level: \> 600 sec

Treatment:

Drug: Tranexamic acid

High dose tranexamic acid + low ACT level

Active Comparator group

Description:

high dose tranexamic acid: 50mg/kg ACT level: 400\~ 600 sec

Treatment:

Drug: Tranexamic acid

Low dose tranexamic acid + low ACT level

Active Comparator group

Description:

Low dose tranxeamic acid: 20mg/kg ACT level: 400\~ 600 sec

Treatment:

Drug: Tranexamic acid

Low dose tranexamic acid + high ACT level

Placebo Comparator group

Description:

Low dose tranxeamic acid: 20mg/kg ACT level: \> 600 sec

Treatment:

Drug: Tranexamic acid