Bedside Evaluation of Coagulation in Children With Congenital Heart Disease (POCHEMO)
"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.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Vaud
-
Lausanne, Vaud, Svizzera, 1011
- PICU, Centre Hospitalier Universitaire Vaudois
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Cardiopulmonary bypass
Children with congenital heart defect undergoing surgery on cardiopulmonary bypass
|
|
cardiac catheterism
Children with congenital heart defect undergoing cardiac catheterism
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Hemostasis measured by thromboelastometry and impedance aggregometry
Lasso di tempo: 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
Lasso di tempo: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Thromboelastometry and impedance aggregometry changes after cardiopulmonary bypass (CPB)
Lasso di tempo: 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
Lasso di tempo: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Stefano Di Bernardo, MD, CHUV
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 468/14
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Disturbo della coagulazione del sangue
-
Andrew Hantel, MDNon ancora reclutamentoMieloma multiplo | Cancro al seno triplo negativo | Duffy Blood Group, Chemokine Receptor Gene Mutation | Duffy Blood Group, Chemokine Receptor Gene C.-67T>CStati Uniti
-
Hangzhou Agile Groups Network Technology Co., Ltd.CompletatoAnemia | Condizione della pelle | Sindrome da carenza di blind Qi-BLOODCina
-
Zhongnan HospitalReclutamentoMicrotrapianto di UCB (Cord Blood) nel trattamento della leucemia mieloide acuta (AML) di nuova diagnosiCina