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A Pilot Study Comparing Anti-Inflammatory Effects Of TXA Versus EACA In Pediatric Congenital Heart Surgery

NCT02656472 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-10-24

Study results available
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Summary

The purpose of this study is to compare anti-inflammatory effects of two anti-fibrinolytic drugs (Tranexamic acid versus Epsilon-aminocaproic acid) in pediatric patients undergoing pediatric cardiac surgery.

Conditions

  • Pediatric Cardiac Surgery
  • Complication of Extracorporeal Circulation

Interventions

DRUG

Epsilon Aminocaproic Acid

Aminocaproic acid Loading dose: 75 mg/kg diluted to 2 ml/kg NS

DRUG

Tranexamic acid

TXA Loading dose: 31 mg/kg diluted to 2 ml/kg Normal saline (NS) -in syringe

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Andrew VanBergen, M.D. · Director, Section of Pediatric Cardiac Critical Care

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • United States

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 NCT02656472 on ClinicalTrials.gov