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Enoxaparin in Children With Asymptomatic Venous Thrombosis After Pediatric Cardiac Surgery

25 augusti 2013 uppdaterad 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?

Studieöversikt

Status

Indragen

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Inte äldre än 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Ingen behandling
Experimentell: 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.
Läkemedel: Enoxaparin
Lovenox- Enoxaparin; Sanofi-Aventis Canada Inc.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Net therapeutic benefit of enoxaparin
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rate of objective clot size progression (or regression)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 18 months post-surgery
Age appropriate PedsQL® generic module and parent report and Child Health Questionnaire
18 months post-surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Hospital for Sick Children

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2011

Primärt slutförande (Förväntat)

1 augusti 2015

Avslutad studie (Förväntat)

1 augusti 2015

Studieregistreringsdatum

Först inskickad

15 november 2011

Först inskickad som uppfyllde QC-kriterierna

17 november 2011

Första postat (Uppskatta)

18 november 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

27 augusti 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 augusti 2013

Senast verifierad

1 augusti 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1000022022

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