Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT01648712
Brief 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.
Study:
NCT01648712
Study Brief:
Protocol Section:
NCT01648712