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

24. januar 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 16 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Children with congenital heart defect

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Cardiopulmonary bypass
Children with congenital heart defect undergoing surgery on cardiopulmonary bypass
cardiac catheterism
Children with congenital heart defect undergoing cardiac catheterism

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Hemostasis measured by thromboelastometry and impedance aggregometry
Tidsramme: 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
Tidsramme: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
Single measurement, during general anesthesia, immediately before procedure, when arterial line available

Sekundære resultatmål

Resultatmål
Tidsramme
Thromboelastometry and impedance aggregometry changes after cardiopulmonary bypass (CPB)
Tidsramme: 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
Tidsramme: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
Single measurement, during general anesthesia, immediately before procedure, when arterial line available

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire Vaudois

Efterforskere

  • Ledende efterforsker: Stefano Di Bernardo, MD, CHUV

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2015

Primær færdiggørelse (Faktiske)

6. juli 2017

Studieafslutning (Faktiske)

7. juli 2017

Datoer for studieregistrering

Først indsendt

5. marts 2015

Først indsendt, der opfyldte QC-kriterier

12. marts 2015

Først opslået (Skøn)

13. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 468/14

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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