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

January 24, 2018 updated by: David Longchamp, Centre Hospitalier Universitaire Vaudois

"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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • PICU, Centre Hospitalier Universitaire Vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with congenital heart defect

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemostasis measured by thromboelastometry and impedance aggregometry
Time Frame: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
Single measurement, during general anesthesia, immediately before procedure, when arterial line available
Hemostasis measured by thromboelastometry and impedance aggregometry in cyanotic children
Time Frame: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
Single measurement, during general anesthesia, immediately before procedure, when arterial line available

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
Single measurement, during general anesthesia, immediately before procedure, when arterial line available

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Stefano Di Bernardo, MD, CHUV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

July 6, 2017

Study Completion (Actual)

July 7, 2017

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 12, 2015

First Posted (Estimate)

March 13, 2015

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 468/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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