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Enoxaparin in Children With Asymptomatic Venous Thrombosis After Pediatric Cardiac Surgery

25. august 2013 oppdatert av: Brian McCrindle, The Hospital for Sick Children

A Randomized Controlled Trial of Enoxaparin in Children With Asymptomatic Venous Thrombosis After Pediatric Cardiac Surgery

The CATCH-enoxaparin trial is the natural continuation of the CATCH study. It will capitalize on the fact that patients enrolled in the CATCH study will be specifically screened for asymptomatic thromboembolism (TEs) in order to answer important clinical questions.

The investigators propose a randomized controlled trial to address whether, among pediatric patients with congenital heart defects (CHD) recovering from cardiovascular surgery and diagnosed with an asymptomatic venous TE, the use of enoxaparin results in a net therapeutic benefit?

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Primary Aim: To address whether, among pediatric patients with congenital heart defects (CHD) recovering from cardiovascular surgery and diagnosed with an asymptomatic venous TE, the use of enoxaparin results in a net therapeutic benefit. We hypothesize that enoxaparin dosed as per age-appropriate algorithms is associated with an increased rate of clot resolution and decreased rate of clot progression/long-term complications in children with CHD and asymptomatic venous TE. Benefits from clot resolution will outweigh the risks associated with the use of enoxaparin resulting in a net therapeutic benefit in favour of enoxaparin use in this context.

Secondary aims of this study are to:

  1. To compare the rate of conversion from asymptomatic to symptomatic TE and/or thromboembolic events between treated and untreated patients. Hypothesis: the use of enoxaparin will significantly reduce the rate of conversion from asymptomatic to symptomatic TE.
  2. To compare the rate of objective clot progression (or regression) by serial imaging with ultrasound and echocardiography between treated and untreated patients. Hypothesis: the use of enoxaparin will significantly increase the rate of clot regression.
  3. To identify factors associated with: TE conversion from asymptomatic to symptomatic, clot resolution and post-thrombotic syndrome in both treated and untreated patients separately. Hypothesis: older children with a more mature coagulation system and those with TEs in superficial vessels (rather than deep/systemic vessels) will have a lower frequency of TE complications.
  4. To establish the rate of bleeding complications (both minor and major) for patients on enoxaparin. Hypothesis: we expect major bleeding complications to be present in 2-3% of treated patients and minor bleeding complications to be frequent.

Studietype

Intervensjonell

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5V1X8
        • The Hospital for Sick Children

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Pediatric patients with a cardiac defect (acquired or congenital)
  2. Recent cardiac surgery (during current hospital admission)3) Presence of a venous clot confirmed by appropriate diagnostic imaging methods associated with either ≥ 25% blood vessel occlusion (clot diameter/vessel diameter) OR is ≥ 3mm in absolute diameter
  3. Enrollment in the Heart Centre Biobank Registry
  4. Enrollment in the CATCH main study

Exclusion Criteria:

  1. Clots associated with any of the following symptoms: swelling, edema, discoloration or high temperature of the affected territory.
  2. Clots in a vascular segment/location (arterial clots, intracardiac clots) or with a degree of vessel occlusion which obligatory warrants treatment
  3. Prosthetic heart valve
  4. Active or previous cancer history
  5. Known congenital coagulopathy or thrombophilic disorder
  6. Liver failure (AST, ALT or % bilirubin 2x normal)
  7. Need for anticoagulation for treatment or prophylaxis for other reasons (e.g. BT shunt, recent thrombosis requiring anticoagulation)
  8. Previous documented residual clot within the same vascular territory affected by current asymptomatic clot
  9. Increased bleeding risk reflected by severe thrombocytopenia (platelet count <30,000/ml) and/or coagulopathy (INR >4.0 or aPTT >120s)
  10. Active bleeding or major bleeding <10 days ago (not surgery related)
  11. Previous neurosurgery <14 days ago
  12. Uncontrolled severe hypertension (>95th percentile for age)
  13. Previous proven diagnosis of heparin-induced-thrombocytopenia (HIT) <100 days ago
  14. Absolute contraindication to heparin/LMWH (e.g. severe heparin allergy)
  15. Pregnancy or breastfeeding
  16. No planned follow-up at The Hospital for Sick Children

While most patients will be identified as part of the CATCH study during the pre-discharge full-body vascular ultrasound, some patients who are not enrolled in CATCH will also be identified if an asymptomatic clot is identified during a clinically indicated radiological study. For those patients who are not already enrolled in the CATCH study and the Heart Centre Biobank Registry, they will be approached and consent will be obtained for those studies prior to enrolment in the CATCH-enoxaparin study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Ingen behandling
Eksperimentell: Treatment group

The initial enoxaparin dose will be: 1.75 mg/kg/dose SC q12h for patients ≤ 2 months old or

1 mg/kg/dose SC q12h for patients > 2 months old

Adjust the dose of enoxaparin according to the following monogram. Depending on the Enoxaparin Anti-factor Xa level achieved, successive actions are indicated, including whether to hold the next scheduled dose, whether any dose change is indicated and when the next anti-factor Xa level should be drawn.
Legemiddel: Enoxaparin
Lovenox- Enoxaparin; Sanofi-Aventis Canada Inc.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Net therapeutic benefit of enoxaparin
Tidsramme: Events recording from baseline to 18 months post-surgery
Defined as the between group difference in proportion of patients with negative outcomes (percent clot conversion to symptomatic + percent major bleeding complications)
Events recording from baseline to 18 months post-surgery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of objective clot size progression (or regression)
Tidsramme: Up to 18 months post-surgery
This will be determined by serial imaging with ultrasound and frequency of complete clot resolution at the end of the treatment
Up to 18 months post-surgery
Frequency and Risk Factors for conversion from asymptomatic to symptomatic thromboembolism
Tidsramme: Up to 18months post-surgery
Defined as the appearance of any of the following symptoms: swelling, edema, discoloration or high temperature of the affected territory
Up to 18months post-surgery
Frequency of and risk factors for post-thrombotic syndrome
Tidsramme: 18 months after surgery
Clinical manifestations include varicose veins, edema, skin hyperpigmentation and skin ulcers
18 months after surgery
Frequency of and risk factors for bleeding complications
Tidsramme: Up to 18months
Minor complications and major episodes defined as cerebral, abdominal, retroperitoneal or pulmonary hemorrhage or any bleeding complications requiring blood transfusions
Up to 18months
Neurodevelopment and health re-lated quality of life
Tidsramme: 18 months post-surgery
Age appropriate PedsQL® generic module and parent report and Child Health Questionnaire
18 months post-surgery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Hospital for Sick Children

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2011

Primær fullføring (Forventet)

1. august 2015

Studiet fullført (Forventet)

1. august 2015

Datoer for studieregistrering

Først innsendt

15. november 2011

Først innsendt som oppfylte QC-kriteriene

17. november 2011

Først lagt ut (Anslag)

18. november 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

27. august 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2013

Sist bekreftet

1. august 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1000022022

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Medisinsk tilstand

Legemiddelintervensjoner

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Forhold

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Legemiddelintervensjoner

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Steder

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