Enoxaparin in Children With Asymptomatic Venous Thrombosis After Pediatric Cardiac Surgery

• Status: Withdrawn
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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?

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Enoxaparin

Criteria

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.