Congenital Heart DefectPOCHEMONCT02387944
Bedside Evaluation of Coagulation in Children With Congenital Heart Disease
An observational study of Congenital Heart Defect and Blood Coagulation Disorder, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Congenital Heart Defect, Blood Coagulation Disorder
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to 7 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with congenital heart defect
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
PICU, Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
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.
Read the 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.
- Keywords
- Children, Cyanotic congenital heart defect, Cardiopulmonary Bypass, Thromboelastometry, Platelet Function Tests
- Medical subject headings
- Heart Defects, Congenital, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiopulmonary bypass | Children with congenital heart defect undergoing surgery on cardiopulmonary bypass | |
| cardiac catheterism | Children with congenital heart defect undergoing cardiac catheterism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis measured by thromboelastometry and impedance aggregometry
Measured: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
Hemostasis measured by thromboelastometry and impedance aggregometry in cyanotic children
Measured: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
Secondary outcomes (2)
Thromboelastometry and impedance aggregometry changes after cardiopulmonary bypass (CPB)
Measured: 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
Measured: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion6 Jul 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Longchamp, Centre Hospitalier Universitaire Vaudois
- Investigators
- Stefano Di Bernardo, MD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387944
- Sponsor's protocol ID
- 468/14
- Acronym
- POCHEMO
- Status last verified
- Jan 2018
- First submitted
- 5 Mar 2015
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Longchamp D, Perez MH, Natterer J, Amiet V, Ferry T, Boegli Y, Mauron S, Dolci M, Plaza Wuthrich S, Di Bernardo S. Point-of-care hemostasis in children with congenital heart disease, the POCHEMO study: baseline reference values of thromboelastometry and impedance aggregometry. Blood Coagul Fibrinolysis. 2019 Jul;30(5):199-204. doi: 10.1097/MBC.0000000000000818.
PubMed 31157681
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Point-Of-Care" Evaluation of Hemostasis in Children With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02387944
- Acronym / sponsor ID
- POCHEMO / 468/14
- Keywords
- Children, Cyanotic congenital heart defect, Cardiopulmonary Bypass, Thromboelastometry, Platelet Function Tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary bypass | – | –Children with congenital heart defect undergoing surgery on cardiopulmonary bypass |
| cardiac catheterism | – | –Children with congenital heart defect undergoing cardiac catheterism |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with congenital heart defect
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemostasis measured by thromboelastometry and impedance aggregometry
Time frame: 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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Derived from this study: PubMed 31157681Longchamp D, Perez MH, Natterer J, Amiet V, Ferry T, Boegli Y, Mauron S, Dolci M, Plaza Wuthrich S, Di Bernardo S. Point-of-care hemostasis in children with congenital heart disease, the POCHEMO study: baseline reference values of thromboelastometry and impedance aggregometry. Blood Coagul Fibrinolysis. 2019 Jul;30(5):199-204. doi: 10.1097/MBC.0000000000000818.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Di Bernardo, MD principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Defect and Blood Coagulation Disorder, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostasis measured by thromboelastometry and impedance aggregometry (time frame: Single measurement, during general anesthesia, immediately before procedure, when arterial line available). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02387944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.