Enoxaparin in Children With Asymptomatic Venous Thrombosis After Pediatric Cardiac Surgery

NCT01474902 | Withdrawn Phase 3 DMC

• 1 other identifier: 1000022022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Asymptotic Venous Thrombosis

Keywords

pediatric; asymptotic venous thrombosis; Enoxaparin; pediatric cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Net therapeutic benefit of enoxaparin

  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

Secondary Outcomes (5)

• Rate of objective clot size progression (or regression)

  Up to 18 months post-surgery

• Frequency and Risk Factors for conversion from asymptomatic to symptomatic thromboembolism

  Up to 18months post-surgery

• Frequency of and risk factors for post-thrombotic syndrome

  18 months after surgery

• Frequency of and risk factors for bleeding complications

  Up to 18months

• Neurodevelopment and health re-lated quality of life

  18 months post-surgery

Study Arms (2)

Treatment group

EXPERIMENTAL

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.

Drug: Enoxaparin

No-treatment

NO INTERVENTION

Interventions

Enoxaparin DRUG

Lovenox- Enoxaparin; Sanofi-Aventis Canada Inc.

Treatment group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients with a cardiac defect (acquired or congenital)
• 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
• Enrollment in the Heart Centre Biobank Registry
• Enrollment in the CATCH main study

You may not qualify if:

• Clots associated with any of the following symptoms: swelling, edema, discoloration or high temperature of the affected territory.
• Clots in a vascular segment/location (arterial clots, intracardiac clots) or with a degree of vessel occlusion which obligatory warrants treatment
• Prosthetic heart valve
• Active or previous cancer history
• Known congenital coagulopathy or thrombophilic disorder
• Liver failure (AST, ALT or % bilirubin 2x normal)
• Need for anticoagulation for treatment or prophylaxis for other reasons (e.g. BT shunt, recent thrombosis requiring anticoagulation)
• Previous documented residual clot within the same vascular territory affected by current asymptomatic clot
• Increased bleeding risk reflected by severe thrombocytopenia (platelet count \<30,000/ml) and/or coagulopathy (INR \>4.0 or aPTT \>120s)
• Active bleeding or major bleeding \<10 days ago (not surgery related)
• Previous neurosurgery \<14 days ago
• Uncontrolled severe hypertension (\>95th percentile for age)
• Previous proven diagnosis of heparin-induced-thrombocytopenia (HIT) \<100 days ago
• Absolute contraindication to heparin/LMWH (e.g. severe heparin allergy)
• Pregnancy or breastfeeding

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Location

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Brian W McCrindle, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 18, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 27, 2013

Record last verified: 2013-08

Locations

CA (1)