Tranexamic Acid in Cyanotic Heart Defects

Postoperative Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244423
• Other study ID #: IRB0000879560
• Status: Completed
• Phase: Phase 2
• First received: August 7, 2017
• Last updated: January 30, 2018
• Start date: January 2009
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery has been described in many studies

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Postoperative Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative blood loss	Blood loss will be measured within first 24 hr.	within the first 24 hours
Secondary	total blood transfusion	ml/kg	within the first 24 hours
Secondary	the interval from protamine to skin closure	the interval from protamine to skin closure	within the first 24 hours
Secondary	the length of ICU stay	by days	within the first month