Platelet Function With New Pediatric Oxygenator and Heparin and Non Heparin Coating in Pediatric Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Days to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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%.
Outcomes
Primary Outcomes
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.
Time Frame: six months
Assuming a reduction of 30% of ß TG in infants treated with Balance TM , a total of 64 infants, 32 on each arm, will be needed to detect a Δ = 246 (mean ß TG = 820ng/ml in group Carmeda and mean ß TG =574ng/ml in group Balance; standard deviation=300) , in the level of ß TG at T2 with a two sided p=0.05 and a power of 80%. Taking in to account the use of non parametric test, we estimated an increase of the calculated sample size of 15%, yielding a total sample size of 74 patients.
Secondary Outcomes
- Platelet mapping by thromboelastography (Hemoscope, Medtronic) will be performed at the following times: T0,T1,T2,T3.(six months)
Investigators
Chiara Giorni
Doctor in Medicine
Hôpital Necker-Enfants Malades