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Three Dose Regimen of Tranexamic Acid in Cardiac Surgery

C

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Unknown

Conditions

Hemostasis

Treatments

Drug: Tranexamic Acid
Drug: Saline Solution

Study type

Interventional

Funder types

Other

Identifiers

NCT01060176
TXA Dosage Trial

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

600 participants in 4 patient groups, including a placebo group

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

Trial contacts and locations

1

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Central trial contact

Lihuan Li, MD; Jia Shi, MD

Data sourced from clinicaltrials.gov

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