Three Dose Regimen of Tranexamic Acid in Cardiac Surgery

Three Dose Regimen of Tranexamic Acid on Blood Loss and Allogeneic Transfusions in Cardiac Surgery With Cardiopulmonary Bypass

Tranexamic acid is thought to be a promising substitute for aprotinin when the latter has seceded in 2007. Yet the ideal dosage and dosing regimen of tranexamic acid in cardiopulmonary bypass cardiac surgery in Chinese population remains controversial. The current study includes patients receiving valvular replacement and coronary artery bypass surgery. Three dosage regimen of tranexamic acid is delivered and blood loss, transfusions and clinical outcomes are recorded.

Study Overview

• Status: Unknown
• Conditions: Hemostasis
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Saline Solution

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lihuan Li, MD; Phone Number: 86-10-88398184; Email: llhfw@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
      • Contact: Lihuan Li, MD; Phone Number: 86-10-88398184; Email: llhfw@sina.com
      • Principal Investigator: Lihuan Li, MD
      • Sub-Investigator: Jia Shi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Rheumatic or recessive valvular disease patients requiring valvular replacement surgery with cardiopulmonary bypass
• Coronary artery disease patients requiring coronary artery bypass surgery with cardiopulmonary bypass
• Wrriten consent obtained

Exclusion Criteria:

• Non-primary cardiac surgery
• Preoperative liver or renal dysfunction
• Preoperative coagulation disorder
• Allergy
• Pregnancy or lactation
• Disabled in spirit or law
• Fatal conditions such as tumour

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Saline solution	Drug: Saline Solution
Experimental: High dosage; Tranexamic acid with a loading dose of 30 mg/kg and a maintenance infusion of 20 mg/kg/h	Drug: Tranexamic Acid
Experimental: Medium dosage; Tranexamic acid with a loading dose of 20 mg/kg and a maintenance infusion of 15 mg/kg/h	Drug: Tranexamic Acid
Experimental: Low dosage; Tranexamic acid with a loading dose of 10 mg/kg and a maintenance infusion of 10 mg/kg/h	Drug: Tranexamic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of exposure to allogeneic erythrocytes transfusions	Allogeneic RBCs were transfused if the hemoglobin level was less than 6 g/dL during cardiopulmonary bypass, less than 8 g/dL postoperatively, or less than 9 g/dL for elderly people (>70 years).	Perioperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in ICU and hospital postoperatively		Postoperatively
Volume of allogeneic erythrocytes transfusions	Allogeneic RBCs were transfused if the hemoglobin level was less than 6 g/dL during cardiopulmonary bypass, less than 8 g/dL postoperatively, or less than 9 g/dL for elderly people (>70 years).	Perioperatively
Rate and volume of fresh frozen plasma transfusion		Perioperatively
Rate and volume of allogeneic platelet transfusion		Perioperatively
Rate of reexploration for hemostasis		Perioperatively
Postoperative blood loss	Defined as total volume of chest drainage postoperatively	Postoperatively
Thromboelastography		Perioperatively
Coagulatory and fibrinolytic associated moleculars	FIB, FDP, FXI:C, AT-III, D-dimer and TXB2	Perioperatively
Inflammation associated moleculars	ET-1, IL-2, IL-6, IL-8, IL-10, TNF-α, NE, FN and PGI2	Perioperatively

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Investigators: Principal Investigator: Jia Shi, MD, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC; Study Chair: Lihuan Li, MD, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 28, 2010
• First Submitted That Met QC Criteria: February 1, 2010
• First Posted (Estimate): February 2, 2010

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: tranexamic acid; hemostasis; cardiac surgery procedures
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TXA Dosage Trial