Tranexamic Acid in Pediatric Cardiac Surgery

Study Overview
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Brief Summary
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Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery. Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict results. The reason why they showed mixed results would be the imbalance of patients population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric cardiac surgery with well balanced patients population.

Official Title
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Tranexamic Acid Reduces Blood Loss in Pediatric Cardiac Surgery

Conditions
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Blood Loss, Congenital Heart Disease

Intervention / Treatment
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* Drug: Tranexamic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children undergoing elective cardiac surgery with cardiopulmonary bypass Exclusion Criteria: neonate born within 1 month preoperative inotropes preoperative mechanical ventilation preexisting coagulation disorder reoperation within 48 hours significant liver or kidney disease known allergy to TXA

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic acid<br>50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit. | Drug: Tranexamic Acid<br>* 50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit in TXA group. same volume of normal saline was given in Placebo group.<br>* Other names: lysin analogue;|
| Placebo Comparator: Placebo<br>same volume of normal saline was given. | Drug: Tranexamic Acid<br>* 50 mg/kg of tranexamic acid was given as a bolus at the induction of anesthesia, followed by 15 mg/kg of continuous infusion and another 50 mg/kg into the bypass circuit in TXA group. same volume of normal saline was given in Placebo group.<br>* Other names: lysin analogue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery |  | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss 6 hours after surgery |  | 6 hours after surgery | 
| the amount of blood transfusion |  | 24 hour after surgery | 
| additional TXA administration |  | 24 hours after surgery | 
| chest closure time (protamine to skin closure) |  | at the end of surgery | 
| re-exploration of chest for excess bleeding |  | within 24 hours after surgery | 
| duration of mechanical ventilation |  | at the time of extubation | 
| length of stay in intensive care unit |  | at the time of discharge from ICU | 
| episode of thrombotic complication |  | from drug administration to hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric cardiac surgery, bleeding, tranexamic acid, fibrinolysis, blood loss in pediatric cardiac surgery