Tranexamic Acid in Cyanotic Heart Defects

Study Overview
=================
Brief Summary
-----------------
The use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery has been described in many studies

Detailed Description
-----------------
40 patients in each one of the three groups; In control group will receive normal saline, Intravenous Tranexamic acid group received 50 mg / kg intravenousely followed by of 1 mg/kg/hr.for six hours. The topical Tranexamic acid group will have 50 mg / kg of tranexamic poured into the pericoredial cavity. in the first 24 hours we will measure the total blood loss and transfusion requirements. Complate blood picture and coagulation studies will be recorded. the occurrence of re-exploration for excess bleeding, or adverse events.

Official Title
-----------------
Tranexamic Acid in Cyanotic Heart Defects: a Risk-benefit Analysis.

Conditions
-----------------
Postoperative Hemorrhage

Intervention / Treatment
-----------------
* Drug: Normal saline at induction
* Drug: Normal saline infusion
* Drug: Intravenous tranexamic acid
* Drug: infusion tranexamic acid
* Drug: topical tranexamic acid
* Drug: topical normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2 to 12 years cyanotic cardiac disease with cardio pulmonary bypass Exclusion Criteria: Previous cardiac surgery any operation within 48 hr., previous inotropes or mechanical vention aprotinin exposure Liver or renal impairment Coagulation or hemostatic dysfunction within the last 7 days before surgery.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>In control group will receive normal saline, | Drug: Normal saline at induction<br>* 0.5 ml/kg<br>Drug: Normal saline infusion<br>* 1ml/kg/hr. during surgery for six hours<br>Drug: topical normal saline<br>* 2 ml/kg into the pericardial cavity before sternal closure<br>|
| Active Comparator: Group 2<br>Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours | Drug: Intravenous tranexamic acid<br>* 50 mg/kg<br>Drug: infusion tranexamic acid<br>* 1mg/kg/hr infusionfor 6 hours<br>Drug: topical normal saline<br>* 2 ml/kg into the pericardial cavity before sternal closure<br>|
| Active Comparator: Group 3<br>the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure. | Drug: Normal saline at induction<br>* 0.5 ml/kg<br>Drug: Normal saline infusion<br>* 1ml/kg/hr. during surgery for six hours<br>Drug: topical tranexamic acid<br>* 50 mg/kg added to the normal saline 2 ml/kg into the pericardial cavity before sternal closure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative blood loss | Blood loss will be measured within first 24 hr. | within the first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total blood transfusion | ml/kg | within the first 24 hours | 
| the interval from protamine to skin closure | the interval from protamine to skin closure | within the first 24 hours | 
| the length of ICU stay | by days | within the first month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric, Cyanotic heart disease, Tranexamic acid, Postoperative blood loss