Three Dose Regimen of Tranexamic Acid in Cardiac Surgery

Not Applicable

• Conditions: Hemostasis
• Interventions: Drug: Tranexamic Acid; Drug: Saline Solution

• Registration Number: NCT01060176
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-28
• Study Start: 2010-02
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-05
• Primary Completion: 2019-08
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dosage	Tranexamic Acid	Tranexamic acid with a loading dose of 30 mg/kg and a maintenance infusion of 20 mg/kg/h
Medium dosage	Tranexamic Acid	Tranexamic acid with a loading dose of 20 mg/kg and a maintenance infusion of 15 mg/kg/h
Low dosage	Tranexamic Acid	Tranexamic acid with a loading dose of 10 mg/kg and a maintenance infusion of 10 mg/kg/h
Control	Saline Solution	Saline solution

Primary Outcome Measures

Name	Time	Method
Rate of exposure to allogeneic erythrocytes transfusions	Perioperatively	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).

Secondary Outcome Measures

Name	Time	Method
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	Postoperatively	Defined as total volume of chest drainage postoperatively
Thromboelastography	Perioperatively
Coagulatory and fibrinolytic associated moleculars	Perioperatively	FIB, FDP, FXI:C, AT-III, D-dimer and TXB2
Inflammation associated moleculars	Perioperatively	ET-1, IL-2, IL-6, IL-8, IL-10, TNF-α, NE, FN and PGI2
Length of stay in ICU and hospital postoperatively	Postoperatively
Volume of allogeneic erythrocytes transfusions	Perioperatively	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).

Trial Locations

Locations (1)

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC; 🇨🇳 Beijing, Beijing, China