"Point-Of-Care" Evaluation of Hemostasis in Children With Congenital Heart Disease

Bedside Evaluation of Coagulation in Children With Congenital Heart Disease

Sponsors

Lead sponsor: Centre Hospitalier Universitaire Vaudois

Source Centre Hospitalier Universitaire Vaudois
Brief 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.

Detailed Description

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.

Overall Status Completed
Start Date March 2015
Completion Date July 7, 2017
Primary Completion Date July 6, 2017
Study Type Observational
Primary Outcome
Measure Time Frame
Hemostasis measured by thromboelastometry and impedance aggregometry Single measurement, during general anesthesia, immediately before procedure, when arterial line available
Hemostasis measured by thromboelastometry and impedance aggregometry in cyanotic children Single measurement, during general anesthesia, immediately before procedure, when arterial line available
Secondary Outcome
Measure Time Frame
Thromboelastometry and impedance aggregometry changes after cardiopulmonary bypass (CPB) maximum 3 measurements, during surgery and up to 6 hours after end of CBP
Thromboelastometry and impedance aggregometry changes in children with significant bleeding after CPB Single measurement, during general anesthesia, immediately before procedure, when arterial line available
Enrollment 200
Condition
Eligibility

Sampling method: Probability Sample

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: 16 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Stefano Di Bernardo, MD Principal Investigator CHUV
Location
facility PICU, Centre Hospitalier Universitaire Vaudois
Location Countries

Switzerland

Verification Date

January 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Centre Hospitalier Universitaire Vaudois

Investigator full name: David Longchamp

Investigator title: PICU consultant, MD

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Cardiopulmonary bypass

Description: Children with congenital heart defect undergoing surgery on cardiopulmonary bypass

Arm group label: cardiac catheterism

Description: Children with congenital heart defect undergoing cardiac catheterism

Acronym POCHEMO
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov