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Tranexamic Acid in Cyanotic Heart Defects

NCT03244423 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-01-31

No results posted yet for this study

Summary

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

Conditions

  • Postoperative Hemorrhage

Interventions

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Sayed k Abd-Elshafy, MD · Associate profossor of anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03244423 on ClinicalTrials.gov