Asymptotic Venous Thrombosis Clinical Trial
Official title:
A Randomized Controlled Trial of Enoxaparin in Children With Asymptomatic Venous Thrombosis After Pediatric Cardiac Surgery
| Verified date | August 2013 |
| Source | The Hospital for Sick Children |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
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?
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 18 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | The Hospital for Sick Children | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| The Hospital for Sick Children |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Rate of objective clot size progression (or regression) | 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 | No |
| Secondary | Frequency and Risk Factors for conversion from asymptomatic to symptomatic thromboembolism | 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 | No |
| Secondary | Frequency of and risk factors for post-thrombotic syndrome | Clinical manifestations include varicose veins, edema, skin hyperpigmentation and skin ulcers | 18 months after surgery | No |
| Secondary | Frequency of and risk factors for bleeding complications | Minor complications and major episodes defined as cerebral, abdominal, retroperitoneal or pulmonary hemorrhage or any bleeding complications requiring blood transfusions | Up to 18months | Yes |
| Secondary | Neurodevelopment and health re-lated quality of life | Age appropriate PedsQL® generic module and parent report and Child Health Questionnaire | 18 months post-surgery | No |