Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Enoxaparin

Criteria

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