Tranexamic Acid in Cyanotic Heart Defects

Phase 2

Completed

• Conditions: Postoperative Hemorrhage
• Interventions: Drug: Normal saline at induction; Drug: Intravenous tranexamic acid; Drug: Normal saline infusion; Drug: infusion tranexamic acid; Drug: topical normal saline; Drug: topical tranexamic acid

• Registration Number: NCT03244423
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

2 to 12 years cyanotic cardiac disease with cardio pulmonary bypass

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	topical normal saline	Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours
Group 1	Normal saline at induction	In control group will receive normal saline,
Group 1	Normal saline infusion	In control group will receive normal saline,
Group 2	Intravenous tranexamic acid	Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours
Group 3	Normal saline at induction	the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure.
Group 3	topical tranexamic acid	the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure.
Group 1	topical normal saline	In control group will receive normal saline,
Group 2	infusion tranexamic acid	Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours
Group 3	Normal saline infusion	the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure.

Primary Outcome Measures

Name	Time	Method
postoperative blood loss	within the first 24 hours	Blood loss will be measured within first 24 hr.

Secondary Outcome Measures

Name	Time	Method
the interval from protamine to skin closure	within the first 24 hours	the interval from protamine to skin closure
total blood transfusion	within the first 24 hours	ml/kg
the length of ICU stay	within the first month	by days

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt