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

NCT06109155 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: CF23323A
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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. 1.Does higher dose of tranexamic acid reduce the amount of bleeding and blood transfusion?
2. 2.Does lower ACT level during cardiac surgery reduce the amount of bleeding and blood transfusion?

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 30-day mortality

  30 days

Study Arms (4)

High dose tranexamic acid + high ACT level

ACTIVE COMPARATOR

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

Drug: Tranexamic acid

High dose tranexamic acid + low ACT level

ACTIVE COMPARATOR

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

Drug: Tranexamic acid

Low dose tranexamic acid + low ACT level

ACTIVE COMPARATOR

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

Drug: Tranexamic acid

Low dose tranexamic acid + high ACT level

PLACEBO COMPARATOR

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

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

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.

High dose tranexamic acid + high ACT level; High dose tranexamic acid + low ACT level; Low dose tranexamic acid + high ACT level; Low dose tranexamic acid + low ACT level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult, cardiac surgery with cardiopulmonary bypass

You may not qualify if:

• pregnant
• emergency procedure
• immune compromised
• aortic surgery
• end-stage renal disease
• liver disease
• critical status
• incomplete clinical data

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (2)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

Taichung Veterans General hospital

Taichung, 40705, Taiwan

RECRUITING

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Yung-Szu Wu, MD

CONTACT

0423592525; adconvert98@gmail.com

Yi-Ting Chang, MD

CONTACT

04-23592525; alisonytchang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In the research process, any raw data will be kept and encrypted by the principal investigator, and it will not be accessible or interpretable by others.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: During cardiac surgery with cardiopulmonary bypass support, participants will be divided into 4 groups. During procedure, they will recieve different doses of tranexamic acid and different level of activated clotting time. Then, we will monitor the amount of blood loss and blood transfusion.

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 31, 2023
• Study Start: February 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)