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Recruiting NCT06109155

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

Phase IV Interventional Surgery, Cardiac Tranxemic Acid Activated Clotting Time Heparin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tranexamic acid.
Who it may be relevant to
Registry conditions: Surgery, Cardiac, Tranxemic Acid, Activated Clotting Time, Heparin. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Blood loss [Time frame: 24 hours]
  • blood transfusion [Time frame: procedure time, an average of 6 hours]
Secondary outcome measures (1)
  • 30-day mortality [Time frame: 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Taiwan · 2 centers
  • Taichung Veterans General Hospital — Taichung
  • Taichung Veterans General hospital — Taichung

Identifiers

NCT: NCT06109155 · CF23323A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗