Prospective Trial of Tranexamic Acid in Cardiac Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

955 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-09-30

Brief Summary

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Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is still unknown. We use three different doses to find which is the optimum dose of tranexamic acid in cardiopulmonary bypass cardiac surgery.

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Detailed Description

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Conditions

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C.Surgical Procedure; Cardiac

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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small dose

10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

The loading doses were given in 15 minutes when incision.

medium dose

20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

The loading doses were given in 15 minutes when incision.

large dose

30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

The loading doses were given in 15 minutes when incision.

Interventions

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Tranexamic Acid

The loading doses were given in 15 minutes when incision.

Intervention Type DRUG

Other Intervention Names

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SINE Tranexamic Acid Injection 120902

Eligibility Criteria

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Inclusion Criteria

* Noncyanotic congenital heart disease patients requiring cardiac surgeries under cardiopulmonary bypass
* Rheumatic or recessive valvular disease patients requiring valvular repair or replacement under cardiopulmonary bypass
* Coronary artery disease patients requiring coronary artery bypass graft under cardiopulmonary bypass

Exclusion Criteria

* Non-primary and emergency cardiac surgery
* Disorder in coagulation function before surgery
* Anemia before surgery
* Definite liver and renal dysfunction
* History of stroke
* Pregnancy and lactation
* Disabled in spirit or law
* Fatal conditions such as cancer

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No