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Enoxaparin in Children With Asymptomatic Venous Thrombosis After Pediatric Cardiac Surgery

25. august 2013 opdateret af: 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?

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

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

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 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Ingen behandling
Eksperimentel: 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.
Medicin: Enoxaparin
Lovenox- Enoxaparin; Sanofi-Aventis Canada Inc.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

The Hospital for Sick Children

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. august 2011

Primær færdiggørelse (Forventet)

1. august 2015

Studieafslutning (Forventet)

1. august 2015

Datoer for studieregistrering

Først indsendt

15. november 2011

Først indsendt, der opfyldte QC-kriterier

17. november 2011

Først opslået (Skøn)

18. november 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. august 2013

Sidst verificeret

1. august 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1000022022

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 .

Kliniske forsøg med Enoxaparin

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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