Congenital Heart Defect Clinical Trial
Official title:
"Point-Of-Care" Evaluation of Hemostasis in Children With Congenital Heart Disease
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.
Hemostasis, a main concern during and after any surgical procedure, is traditionally
monitored by the following laboratory tests: activated Partial Thrombin Time (aPTT),
prothrombin time (PT), fibrinogen, platelets count. They neither provide a reliable estimate
of the risk of bleeding, nor allow determining useful interventions.
New investigations of hemostasis are now used and validated during and after surgery:
Rotational Thromboelastometry (ROTEM®) and impedance aggregometry. This is a quick bedside
functional analysis of the patient's clotting. Children who undergo surgery under
cardiopulmonary bypass (CPB) are particularly at risk of bleeding and this population hasn't
been studied with large cohort yet.
Hypothesis: Hemostasis in children with CHD, especially when cyanotic, is intrinsically
abnormal. The corrective surgery on CPB induces further hemostatic disorders which can be
identified by the ROTEM platelet®.
The aim of the study is to evaluate the hemostatic function of the child with congenital
heart disease using a Point-Of-Care (platelet-ROTEM ®) system, before surgery and after
alterations induced by cardiopulmonary bypass (CPB).
This is a single center, observational, prospective study. Expected duration: 2 years. The
investigators plan to include 200 patients with CHD, 100 patients undergoing surgery with CPB
and 100 patients with congenital heart disease requiring cardiac catheterization. Recruitment
will be conducted by the Division of Paediatric Cardiology.
Inclusion criteria include an age of 0-16 years and a diagnosis of congenital heart disease
requiring surgery with CPB or cardiac catheterization. Patients with known dyscrasia or
treated with antiaggregant within 10 days/oral anticoagulants within 48h before
surgery/catheterization.
ROTEM platelet® test will be performed before surgery/catheterization. Patients undergoing
surgery will have a second test within 30 minutes after the end of cardiopulmonary bypass.
All patients will benefit from the usual cares.
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