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Platelet Function With New Pediatric Oxygenator and Heparin and Non Heparin Coating in Pediatric Cardiac Surgery

NCT01648712 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-02-12

No results posted yet for this study

Summary

Optimal anticoagulation is mandatory during CPB in order to avoid hemostatic system activation. Platelet dysfunction is commonly observed after procedures performed under cardiopulmonary bypass (CPB). This is associated with a major risk of thrombosis and bleeding in the postoperative period.

Coating of the surface has been shown to diminish these effects.Biocompatible surfaces, extracorporeal circulation technologies mimic critical characteristics of the vascular endothelium to provide thromboresistance and enhanced blood compatibility. Recently, a new physiologic non heparin coating with different functional aspects was developed as an alternative to heparin based biological coatings. This bio-passive Hydrophilic Polymer Coating Without Heparin (BalanceTM Bio-Passive surface) and pediatric oxygenation system (Affinity PixieTM Oxygenation System), is designed to mimic the natural interfaces of blood. The aim of this study is to compare the influence of a Balance - coated CPB system in pediatric use versus the Carmeda TM heparin-coated system in platelet function preservation and hemostatic activation.

Conditions

  • Acquired Platelet Function Disorder

Interventions

DEVICE

Balance surface, Carmeda heparin-coated surface

This study compares the influence of a Balance - coated CPB system in pediatric use versus the Carmeda TM heparin-coated system in platelet function preservation and hemostatic activation. Balance arm group recieved like intervention a Balance circuit

DEVICE

non -heparin extracorporeal pediatric device for operation

The carmeda arm group received like intervention the Carmeda circuit

Sponsors & Collaborators

  • Bambino Gesù Hospital and Research Institute

    collaborator OTHER

  • Hôpital Necker-Enfants Malades

    lead OTHER

Principal Investigators

  • Chiara Giorni, M.D. · Hopital Necker Enfants Malades

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Days
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • France

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 NCT01648712 on ClinicalTrials.gov