Three Dose Regimen of Tranexamic Acid in Cardiac Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Hemostasis

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Saline Solution


Participation Criteria
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Eligibility Criteria
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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

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

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