Clinical trial · Interventional
Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer
Phase II Study on the Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Futility; unable to complete screening due to clinical practice change
Summary
Brief summary (as posted)
The primary hypothesis of this study is that occult catheter-related DVT in children with cancer is common and directly contributes to development of serious catheter complications, specifically bacteremia/fungemia and/or recurrent occlusion of the catheter tip. Accordingly, anticoagulant treatment of clinically silent (occult) DVT will reduce rates of catheter-related infection and occlusion, delays in therapy and need for catheter replacement.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Catheter-related Infection | — | UNRESOLVED | — |
| Catheter-related Occlusion | — | UNRESOLVED | — |
| Central Venous Catheters | — | UNRESOLVED | — |
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Deep Vein Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enoxaparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A-randomized to treatment
- description
- Patients diagnosed with asymptomatic catheter-related DVT who are randomized to treatment with enoxaparin for 6 weeks
- interventionNames
- Drug: Enoxaparin
- type
- NO_INTERVENTION
- label
- B-randomized to close
- description
- Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation for 6 weeks
Primary outcomes (1)
- measure
- Composite Endpoint for Arm B of the Study: Catheter Removal, Signs and Symptoms of DVT or PE, OR Bacteremia/Fungemia
- timeFrame
- 16 weeks
- description
- catheter removal, signs and symptoms of DVT or PE, OR bacteremia/fungemia
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of cancer 2. Age ≤ 18 years 3. First tunneled central venous catheter (implanted port or external) inserted in the upper venous system (subclavian, brachiocephalic, or jugular vein) within the previous 2 weeks 4. Catheter expected to be in place for duration of chemotherapy (≥ 3 months) 5. History of no more than one catheter complication (occlusion or infection) Exclusion Criteria: 1. Prior history of DVT 2. Currently receiving an anticoagulant or anti-platelet agents on a daily basis 3. Diagnosis of high grade malignant brain tumor or metastasis to the brain 4. Clinical signs/symptoms of DVT 5. Clinical signs/symptoms of Pulmonary embolism 6. Renal failure 7. Recent major hemorrhage
References
Publications (0)
Data not yet available