NCT03244423

Tranexamic Acid in Cyanotic Heart Defects

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Hemorrhage

Interventions

Type	Name	Description
DRUG	Normal saline at induction	0.5 ml/kg
DRUG	Normal saline infusion	1ml/kg/hr. during surgery for six hours
DRUG	Intravenous tranexamic acid	50 mg/kg
DRUG	infusion tranexamic acid	1mg/kg/hr infusionfor 6 hours
DRUG	topical tranexamic acid	50 mg/kg added to the normal saline 2 ml/kg into the pericardial cavity before sternal closure
DRUG	topical normal saline	2 ml/kg into the pericardial cavity before sternal closure

Timeline

• Start date: 2009-01-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2017-08-09
• Last updated: 2018-01-31

Locations

1 site across 1 country: Egypt