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Enoxaparin in Children With Asymptomatic Venous Thrombosis After Pediatric Cardiac Surgery

2013年8月25日 更新者：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?

研究概览

地位

撤销

条件

干预/治疗

详细说明

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.

研究类型

介入性

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Ontario
      • Toronto、Ontario、加拿大、M5V1X8
        • The Hospital for Sick Children

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 18年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：无处理
实验性的：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.
药品：Enoxaparin
Lovenox- Enoxaparin; Sanofi-Aventis Canada Inc.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Net therapeutic benefit of enoxaparin
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Rate of objective clot size progression (or regression)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：18 months post-surgery
Age appropriate PedsQL® generic module and parent report and Child Health Questionnaire
18 months post-surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The Hospital for Sick Children

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年8月1日

初级完成 (预期的)

2015年8月1日

研究完成 (预期的)

2015年8月1日

研究注册日期

首次提交

2011年11月15日

首先提交符合 QC 标准的

2011年11月17日

首次发布 (估计)

2011年11月18日

研究记录更新

最后更新发布 (估计)

2013年8月27日

上次提交的符合 QC 标准的更新

2013年8月25日

最后验证

2013年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 1000022022

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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