Tranexamic Acid in Cyanotic Heart Defects

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Hemorrhage
• Intervention / Treatment: Drug: Normal saline at induction; Drug: Normal saline infusion; Drug: topical normal saline; Drug: Intravenous tranexamic acid; Drug: infusion tranexamic acid; Drug: topical tranexamic acid

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 74111
    • Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Pediatric; Tranexamic acid; Postoperative blood loss; Cyanotic heart disease
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Postoperative Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: IRB0000879560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No