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Tranexamic Acid in Cyanotic Heart Defects

NCT ID: NCT03244423

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2017-08-31

Brief Summary

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

Detailed Description

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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

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Postoperative Hemorrhage

Keywords

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Pediatric Cyanotic heart disease Tranexamic acid Postoperative blood loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group 1

In control group will receive normal saline,

Group Type PLACEBO_COMPARATOR

Normal saline at induction

Intervention Type DRUG

0.5 ml/kg

Normal saline infusion

Intervention Type DRUG

1ml/kg/hr. during surgery for six hours

topical normal saline

Intervention Type DRUG

2 ml/kg into the pericardial cavity before sternal closure

Group 2

Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours

Group Type ACTIVE_COMPARATOR

Intravenous tranexamic acid

Intervention Type DRUG

50 mg/kg

infusion tranexamic acid

Intervention Type DRUG

1mg/kg/hr infusionfor 6 hours

topical normal saline

Intervention Type DRUG

2 ml/kg into the pericardial cavity before sternal closure

Group 3

the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure.

Group Type ACTIVE_COMPARATOR

Normal saline at induction

Intervention Type DRUG

0.5 ml/kg

Normal saline infusion

Intervention Type DRUG

1ml/kg/hr. during surgery for six hours

topical tranexamic acid

Intervention Type DRUG

50 mg/kg added to the normal saline 2 ml/kg into the pericardial cavity before sternal closure

Interventions

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Normal saline at induction

0.5 ml/kg

Intervention Type DRUG

Normal saline infusion

1ml/kg/hr. during surgery for six hours

Intervention Type DRUG

Intravenous tranexamic acid

50 mg/kg

Intervention Type DRUG

infusion tranexamic acid

1mg/kg/hr infusionfor 6 hours

Intervention Type DRUG

topical tranexamic acid

50 mg/kg added to the normal saline 2 ml/kg into the pericardial cavity before sternal closure

Intervention Type DRUG

topical normal saline

2 ml/kg into the pericardial cavity before sternal closure

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sayed Kaoud Abd-Elshafy

Associate Profossor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sayed k Abd-Elshafy, MD

Role: PRINCIPAL_INVESTIGATOR

Associate profossor of anesthesiology

Locations

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Faculty of Medicine

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB0000879560

Identifier Type: -

Identifier Source: org_study_id