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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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12 December 2020 |
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Main ID: |
NCT02387944 |
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Date of registration:
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05/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Bedside Evaluation of Coagulation in Children With Congenital Heart Disease
POCHEMO |
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Scientific title:
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"Point-Of-Care" Evaluation of Hemostasis in Children With Congenital Heart Disease |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02387944 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Stefano Di Bernardo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHUV |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- children between 0 and 16 years, born with a congenital heart disease requiring either
cardiac catheterization or surgery with cardiopulmonary bypass
- parental and/or patient consent
Exclusion Criteria:
- known hemostatic disorder
- known platelet function disorder
- antiaggregation treatment <10 days before blood sampling
- oral anticoagulation <2 days before blood sampling
- intravenous heparin <6 hours before blood sampling
- patient and parents unable to consent
Age minimum:
N/A
Age maximum:
16 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Congenital Heart Defect
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Blood Coagulation Disorder
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Primary Outcome(s)
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Hemostasis measured by thromboelastometry and impedance aggregometry
[Time Frame: Single measurement, during general anesthesia, immediately before procedure, when arterial line available]
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Hemostasis measured by thromboelastometry and impedance aggregometry in cyanotic children
[Time Frame: Single measurement, during general anesthesia, immediately before procedure, when arterial line available]
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Secondary Outcome(s)
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Thromboelastometry and impedance aggregometry changes after cardiopulmonary bypass (CPB)
[Time Frame: maximum 3 measurements, during surgery and up to 6 hours after end of CBP]
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Thromboelastometry and impedance aggregometry changes in children with significant bleeding after CPB
[Time Frame: Single measurement, during general anesthesia, immediately before procedure, when arterial line available]
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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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