MedDataX Logo

Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery

NCT ID: NCT04911413

Last Updated: 2021-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2021-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study compares the effect of three different dose levels of tranexamic acid（TXA）in reducing blood loss and transfusion requirements in cardiac valve surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The effect of TXA to reduce perioperative blood loss and blood transfusion has been well established in many trials, but the optimal dosage of TXA in cardiac surgery has always been a problem of debate. This is a single-center randomized controlled trial to study different dose regimens of TXA in cardiac surgery. We use three different dose levels of TXA in cardiac valve surgery with CPB, and see if there are any differences in perioperative blood loss and transfusion requirements. Serious adverse events and seizure attacks are also recorded until three months after surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Surgical Procedures Blood Transfusion Tranexamic Acid

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cardiac Surgery Blood transfusion Blood loss Tranexamic Acid Dose regimen

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

low-dose group,

A bolus of 10 mg/kg Tranexamic Acid followed by a maintenance dose of 10 mg/kg/h Tranexamic Acid until the end of surgery

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.

middle-dose group,

A bolus of 20 mg/kg Tranexamic Acid followed by a maintenance dose of 15 mg/kg/h Tranexamic Acid until the end of surgery

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.

high-dose group

A bolus of 30 mg/kg Tranexamic Acid followed by a maintenance dose of 20 mg/kg/h Tranexamic Acid until the end of surgery

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tranexamic acid

The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cyklokapron Transamin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients aged between 18 to 60 years old scheduled for cardiac valve surgery (replacement or plasty) requiring CPB

Exclusion Criteria

* known allergy to TXA, combined CABG operation or other cardiac procedures other than valve surgery, previous cardiac surgery, EF\<45% or cardiothoracic ratio\>0.65, serious coagulation disorder, serious hepatic insufficiency, receiving antiplatelet therapy at any time within 7 days of surgery, receiving low molecular weight heparin at any time within 24 hours of surgery, and pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

SHI Jia

Director，the department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fuwai Hospital, National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TXA dosage trial 2

Identifier Type: -

Identifier Source: org_study_id