Three Dose Regimen of Tranexamic Acid in Cardiac Surgery

Chinese Academy of Medical Sciences, Fuwai Hospital600 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

600

Conditions

Hemostasis

Interventions

Tranexamic AcidDRUG

Saline SolutionDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: Perioperatively

Secondary Outcomes

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).

Time frame: Perioperatively

Rate and volume of fresh frozen plasma transfusion

Time frame: Perioperatively

Rate and volume of allogeneic platelet transfusion

Time frame: Perioperatively

Rate of reexploration for hemostasis

Time frame: Perioperatively

Postoperative blood loss

Defined as total volume of chest drainage postoperatively

Time frame: Postoperatively

Thromboelastography

Time frame: Perioperatively

Coagulatory and fibrinolytic associated moleculars

FIB, FDP, FXI:C, AT-III, D-dimer and TXB2

Time frame: Perioperatively

Inflammation associated moleculars

ET-1, IL-2, IL-6, IL-8, IL-10, TNF-α, NE, FN and PGI2

Central Contacts

Lihuan Li, MD

CONTACT

86-10-88398184 llhfw@sina.com

Jia Shi, MD

CONTACT

86-10-88322467 shiandypumc@sina.com

Data from ClinicalTrials.gov

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