CompletedNot Applicable

Bedside Evaluation of Coagulation in Children With Congenital Heart Disease

Switzerland200 participantsStarted 2015-03

Plain-language summary

The purpose of this study is to assess coagulation and platelet function in children with congenital heart disease, measured with a bedside device (thromboelastometry and impedance aggregometry). The investigators also aim to determine if this device detect post-cardiopulmonary bypass clotting derangements and may help to manage bleeding in this population.

Who can participate

Age range16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Hemostasis measured by thromboelastometry and impedance aggregometry

Timeframe: Single measurement, during general anesthesia, immediately before procedure, when arterial line available

Hemostasis measured by thromboelastometry and impedance aggregometry in cyanotic children

Timeframe: Single measurement, during general anesthesia, immediately before procedure, when arterial line available

Trial details

NCT IDNCT02387944

SponsorCentre Hospitalier Universitaire Vaudois

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-07-06

View on ClinicalTrials.gov More Congenital Heart Defect trials