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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 February 2021 |
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Main ID: |
NCT01648712 |
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Date of registration:
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20/07/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Platelet Function With New Pediatric Oxygenator and Heparin and Non Heparin Coating in Pediatric Cardiac Surgery
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Scientific title:
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Platelet Function With New Pediatric Oxygenator and Heparin and Non Heparin Coating in Pediatric Cardiac Surgery |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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48 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01648712 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Chiara Giorni, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Necker Enfants Malades |
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Key inclusion & exclusion criteria
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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%.
Age minimum:
N/A
Age maximum:
5 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acquired Platelet Function Disorder
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Intervention(s)
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Device: Balance surface, Carmeda heparin-coated surface
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Device: non -heparin extracorporeal pediatric device for operation
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Platelet mapping by thromboelastography (Hemoscope, Medtronic) will be performed at the following times: T0,T1,T2,T3.
[Time Frame: six months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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