Three Dose Regimen of Tranexamic Acid in Cardiac Surgery

Hemostasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01060176
• Other study ID #: TXA Dosage Trial
• Status: Recruiting
• Phase: N/A
• Start date: February 2010
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Lihuan Li, MD
• Phone: 86-10-88398184
• Email: llhfw[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemostasis

Intervention

Drug:
• Tranexamic Acid

• Saline Solution

Locations

Country	Name	City	State
China	Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rate and volume of fresh frozen plasma transfusion		Perioperatively
Secondary	Rate and volume of allogeneic platelet transfusion		Perioperatively
Secondary	Rate of reexploration for hemostasis		Perioperatively
Secondary	Postoperative blood loss	Defined as total volume of chest drainage postoperatively	Postoperatively
Secondary	Thromboelastography		Perioperatively
Secondary	Coagulatory and fibrinolytic associated moleculars	FIB, FDP, FXI:C, AT-III, D-dimer and TXB2	Perioperatively
Secondary	Inflammation associated moleculars	ET-1, IL-2, IL-6, IL-8, IL-10, TNF-a, NE, FN and PGI2	Perioperatively
Secondary	Length of stay in ICU and hospital postoperatively		Postoperatively