Prospective Trial of Tranexamic Acid in Cardiac Surgery

Study Overview
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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.

Official Title
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A Randomized Double-blinded Trial to Explore the Optimum Dose of Tranexamic Acid in Cardiopulmonary Bypass Cardiac Surgery

Conditions
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C.Surgical Procedure; Cardiac

Intervention / Treatment
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* Drug: Tranexamic Acid


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: small dose<br>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 | Drug: Tranexamic Acid<br>* The loading doses were given in 15 minutes when incision.<br>* Other names: 120902;|
| Experimental: medium dose<br>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 | Drug: Tranexamic Acid<br>* The loading doses were given in 15 minutes when incision.<br>* Other names: 120902;|
| Experimental: large dose<br>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 | Drug: Tranexamic Acid<br>* The loading doses were given in 15 minutes when incision.<br>* Other names: 120902;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Blood Loss |  | 24hrs postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Needs Allogenic Transfusion |  | on the 7th day postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid, cardiac surgery, cardiopulmonary bypass