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

NCT ID: NCT01648712

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-04-30

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.

Conditions

Acquired Platelet Function Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Balance Circuit

24 patients will be assigned to the Balance group , using a non -heparin extracorporeal pediatric device for operation . The intervention is to use the Balance circuit for this arm

Group Type: OTHER

non -heparin extracorporeal pediatric device for operation

Intervention Type: DEVICE

The carmeda arm group received like intervention the Carmeda circuit

Carmeda Circuit

24 patients will be assigned to the Carmeda group, using a coated heparin extracorporeal pediatric device for operation.

The intervention is to use the Carmeda circuit for this arm. The intervention is the Carmeda circuit.

Group Type: OTHER

Balance surface, Carmeda heparin-coated surface

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

non -heparin extracorporeal pediatric device for operation

The carmeda arm group received like intervention the Carmeda circuit

Intervention Type: DEVICE

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%.

• Minimum Eligible Age: 30 Days
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bambino Gesù Hospital and Research Institute

OTHER

Sponsor Role: collaborator

Hôpital Necker-Enfants Malades

OTHER

Sponsor Role: lead

Responsible Party

Chiara Giorni

Doctor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chiara Giorni, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hopital Necker Enfants Malades

Locations

Hopital Necker Enfants Malades

Paris, , France

Countries

France

Other Identifiers

Necker

Identifier Type: -

Identifier Source: org_study_id