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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Hôpital Necker-Enfants Malades.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Bambino Gesù Hospital and Research Institute
Information provided by (Responsible Party):
Chiara Giorni, Hôpital Necker-Enfants Malades
ClinicalTrials.gov Identifier:
NCT01648712
First received: July 20, 2012
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Acquired Platelet Function Disorder
Device: Balance surface, Carmeda heparin-coated surface
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Platelet Function With New Pediatric Oxygenator and Heparin and Non Heparin Coating in Pediatric Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Hôpital Necker-Enfants Malades:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Platelet mapping by thromboelastography (Hemoscope, Medtronic) will be performed at the following times: T0,T1,T2,T3. [ Time Frame: six months ] [ Designated as safety issue: No ]

    Flow cytometry will be analysed at T0, T1,T2. Fibrinogen levels, platelet count, prothrombin time, thrombin-antithrombin complex (TAT), F 1+2, PF4 , will be analysed at each time of the study.

    Differences of bleeding, and transfusion of any blood product, during the first postoperative 24 hours, will be collected.

    Analysis of differences of activation at different times, for two different temperatures, used for CPB in the two centers.

    Need of surgical review for bleeding, time of intubation, length of stay in ICU will be analyzed.



Estimated Enrollment: 74
Study Start Date: September 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Balance Circuit, Carmeda Circuit

Prospective, randomized double-blind, double center, phase IV clinical trial comparing heparin (Carmeda TM) and non-heparin (BalanceTM Bio-Passive surface) extracorporeal pediatric circuit for congenital heart disease repair .

74 infants/children will be divided in two groups, 37 patients will be assigned to the Balance group and 37 patients to the Carmeda group.

Device: 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.
Active Comparator: Bypass Circuit

Prospective, randomized double-blind, double center, phase IV clinical trial comparing heparin (Carmeda TM) and non-heparin (BalanceTM Bio-Passive surface) extracorporeal pediatric circuit for congenital heart disease repair .

74 infants/children will be divided in two groups, 37 patients will be assigned to the Balance group and 37 patients to the Carmeda group.

Device: 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.

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

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants/children (weighting less than 15 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%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648712

Contacts
Contact: Chiara Giorni, M.D: 00393473658622 c_giorni@yahoo.it

Locations
France
Hopital Necker Enfants Malades Not yet recruiting
Paris, France, 75743
Contact: Chiara Giorni, M.D.    00393473658622      
Principal Investigator: Chiara Giorni         
Sponsors and Collaborators
Hôpital Necker-Enfants Malades
Bambino Gesù Hospital and Research Institute
Investigators
Principal Investigator: Chiara Giorni, M.D. Hopital Necker Enfants Malades
  More Information

No publications provided

Responsible Party: Chiara Giorni, Doctor in Medicine, Hôpital Necker-Enfants Malades
ClinicalTrials.gov Identifier: NCT01648712     History of Changes
Other Study ID Numbers: Necker
Study First Received: July 20, 2012
Last Updated: August 2, 2012
Health Authority: Italy: Ethics Committee
France: Committee for the Protection of Personnes

Keywords provided by Hôpital Necker-Enfants Malades:
extracorporeal circuit, platelet function

Additional relevant MeSH terms:
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 20, 2014