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

NCT04911413 | Completed Phase 4

• 1 other identifier: TXA dosage trial 2
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Surgical Procedures; Blood Transfusion; Tranexamic Acid

Keywords

Cardiac Surgery; Blood transfusion; Blood loss; Tranexamic Acid; Dose regimen

Outcome Measures

Primary Outcomes (1)

• total postoperative drainage

  The total chest tube drainage postoperatively

  from the operation day to the discharge，an average of 7 days

Secondary Outcomes (7)

• Red blood cells transfusion rate（%），Red blood cells transfusion volume（ml）

  from the operation day to the discharge，an average of 7 days

• Fresh frozen plasma transfusion rate（%），Fresh frozen plasma transfusion volume（ml）

  from the operation day to the discharge，an average of 7 days

• Platelet transfusion rate（%），Platelet transfusion volume（ml）

  from the operation day to the discharge，an average of 7 days

• repeat surgery because of bleeding

  from the operation day to the discharge，an average of 7 days

• rate of death

  from the operation day to three months after surgery

Study Arms (3)

low-dose group,

EXPERIMENTAL

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

Drug: Tranexamic acid

middle-dose group,

EXPERIMENTAL

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

Drug: Tranexamic acid

high-dose group

EXPERIMENTAL

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

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

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

Also known as: Cyklokapron, Transamin

high-dose group; low-dose group,; middle-dose group,

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director，the department of Anesthesiology

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 3, 2021
• Study Start: September 1, 2017
• Primary Completion: March 5, 2021
• Study Completion: June 15, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)