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Bedside Evaluation of Coagulation in Children With Congenital Heart Disease (POCHEMO)

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ClinicalTrials.gov Identifier: NCT02387944
Recruitment Status : Completed
First Posted : March 13, 2015
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
David Longchamp, 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.


Condition or disease
Congenital Heart Defect Blood Coagulation Disorder

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.


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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: "Point-Of-Care" Evaluation of Hemostasis in Children With Congenital Heart Disease
Study Start Date : March 2015
Actual Primary Completion Date : July 6, 2017
Actual Study Completion Date : July 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Group/Cohort
Cardiopulmonary bypass
Children with congenital heart defect undergoing surgery on cardiopulmonary bypass
cardiac catheterism
Children with congenital heart defect undergoing cardiac catheterism



Primary Outcome Measures :
  1. Hemostasis measured by thromboelastometry and impedance aggregometry [ Time Frame: Single measurement, during general anesthesia, immediately before procedure, when arterial line available ]
  2. Hemostasis measured by thromboelastometry and impedance aggregometry in cyanotic children [ Time Frame: Single measurement, during general anesthesia, immediately before procedure, when arterial line available ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with congenital heart defect
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387944


Locations
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Switzerland
PICU, Centre Hospitalier Universitaire Vaudois
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Stefano Di Bernardo, MD CHUV

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Responsible Party: David Longchamp, PICU consultant, MD, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02387944     History of Changes
Other Study ID Numbers: 468/14
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Keywords provided by David Longchamp, Centre Hospitalier Universitaire Vaudois:
Children
Cyanotic congenital heart defect
Cardiopulmonary Bypass
Thromboelastometry
Platelet Function Tests

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Blood Coagulation Disorders
Hemostatic Disorders
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Hematologic Diseases
Vascular Diseases
Hemorrhagic Disorders