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

Sponsor

Taichung Veterans General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06109155

Collaborator

(none)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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:

Does higher dose of tranexamic acid reduce the amount of bleeding and blood transfusion?
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.

Condition or Disease	Intervention/Treatment	Phase
Surgery, Cardiac Tranxemic Acid Activated Clotting Time Heparin Cardiopulmonary Bypass	Drug: Tranexamic acid	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Blood loss [24 hours]
monitor the amount of blood loss after procedure
blood transfusion [procedure time, an average of 6 hours]
the amount of blood transfusion during procedure

Secondary Outcome Measures

30-day mortality [30 days]
30-day mortality after procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Taichung Veterans General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taichung Veterans General Hospital

ClinicalTrials.gov Identifier:

NCT06109155

Other Study ID Numbers:

CF23323A

First Posted:

Oct 31, 2023

Last Update Posted:

Oct 31, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Hemorrhage

Tranexamic Acid

Study Results

No Results Posted as of Oct 31, 2023