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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiopulmonary Bypass; Heparin; Surgery, Cardiac; Tranxemic Acid; Activated Clotting Time
• Intervention / Treatment: Drug: Tranexamic acid

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yung-Szu Wu, MD; Phone Number: 5063 0423592525; Email: adconvert98@gmail.com
• Study Contact Backup: Name: Yi-Ting Chang, MD; Phone Number: 5062 04-23592525; Email: alisonytchang@gmail.com

Study Locations

• Taiwan
  • Taichung, Taiwan, 40705
    • Recruiting
    • Taichung Veterans General Hospital
    • Contact: Yung Szu Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High dose tranexamic acid + high ACT level; high dose tranexamic acid: 50mg/kg ACT level: > 600 sec	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.
Active Comparator: High dose tranexamic acid + low ACT level; high dose tranexamic acid: 50mg/kg ACT level: 400~ 600 sec	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.
Active Comparator: Low dose tranexamic acid + low ACT level; Low dose tranxeamic acid: 20mg/kg ACT level: 400~ 600 sec	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.
Placebo Comparator: Low dose tranexamic acid + high ACT level; Low dose tranxeamic acid: 20mg/kg ACT level: > 600 sec	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	monitor the amount of blood loss after procedure	24 hours
blood transfusion	the amount of blood transfusion during procedure	procedure time, an average of 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality	30-day mortality after procedure	30 days

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: CF23323A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes