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

NCT01648712 | Terminated DMC

• 1 other identifier: Necker
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Platelet Function Disorder

Keywords

extracorporeal circuit, platelet function

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  six months

Secondary Outcomes (1)

• Platelet mapping by thromboelastography (Hemoscope, Medtronic) will be performed at the following times: T0,T1,T2,T3.

  six months

Study Arms (2)

Balance Circuit

OTHER

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

Device: non -heparin extracorporeal pediatric device for operation

Carmeda Circuit

OTHER

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.

Device: Balance surface, Carmeda heparin-coated surface

Interventions

Balance surface, Carmeda heparin-coated surface 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

Carmeda Circuit

non -heparin extracorporeal pediatric device for operation DEVICE

The carmeda arm group received like intervention the Carmeda circuit

Balance Circuit

Eligibility Criteria

• Age: 30 Days - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Hôpital Necker-Enfants Malades: lead
• Bambino Gesù Hospital and Research Institute: collaborator

Study Sites (1)

Hopital Necker Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Chiara Giorni, M.D.

  Hopital Necker Enfants Malades

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Medicine

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 24, 2012
• Study Start: March 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

FR (1)