NCT01648712

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Hôpital Necker-Enfants Malades · Academic / Other
• Sex: All
• Age: 30 Days – 5 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Since the coagulation system and platelets are involved in the blood activation process, a coating might be a valuable approach to inhibit the different reactions. Improving the biocompatibility of the system by reduction of contact activation of blood elements is of significant importance, especially for neonates and infants who are more susceptible to the deleterious effects of extracorporeal circulation (ECC). Biocompatible surfaces extracorporeal circulation technologies mimic critical characteristics of the vascular endothelium to provide thromboresistance and enhanced blood compatibility. These biocompatible surfaces mitigate the foreign body response that occurs when blood comes in contact with non- endothelial surfaces. 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.

Conditions

• Acquired Platelet Function Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2012-07-24
• Last updated: 2021-02-12

Locations

1 site across 1 country: France