Clinical trial NCT01648712: Platelet Function With New Pediatric Oxygenator and Heparin and Non Heparin Coating in Pediatric Cardiac Surgery
Official title: Platelet Function With New Pediatric Oxygenator and Heparin and Non Heparin Coating in Pediatric Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acquired Platelet Function Disorder
Keywords: extracorporeal circuit, platelet function
Lead sponsor: Hôpital Necker-Enfants Malades
Sponsor class: OTHER
Collaborators: name: Bambino Gesù Hospital and Research Institute
First posted: 2012-07-24
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* Infants/children (weighting less than 18 Kg) undergoing surgical repair of congenital heart defects on CPB, presenting a saturation \> 85% preoperatively.

Exclusion Criteria:

* Newborns, infants/children with Down syndrome, other syndromes or chromosomal abnormalities prematurity,
* use of circulatory arrest,
* expected perfusion time \< 1 hour, documented coagulation disorders, use of anticoagulant or antiplatelet drugs within 48 hours of surgery, previous heart surgery and procedures requiring a return on CPB (2 or more CPB runs),
* cyanosis defined as oxygen saturation lower than 85%.

Primary outcomes:
measure: The primary endpoint will be the difference in levels of ß thromboglobulin (ß TG) at T2 (15 min after end of bypass) between the two groups.
timeFrame: six months
Secondary outcomes:
measure: Platelet mapping by thromboelastography (Hemoscope, Medtronic) will be performed at the following times: T0,T1,T2,T3.
timeFrame: six months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Necker Enfants Malades
Study officials:
affiliation: Hopital Necker Enfants Malades
name: Chiara Giorni, M.D.
role: PRINCIPAL_INVESTIGATOR
References: