Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Childr… (NCT00633061) | Clinical Trial Compass
TerminatedPhase 2
Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer
Stopped: Futility; unable to complete screening due to clinical practice change
United States136 participantsStarted 2008-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosis of cancer
✓. Age ≤ 18 years
✓. 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
✓. Catheter expected to be in place for duration of chemotherapy (≥ 3 months)
✓. History of no more than one catheter complication (occlusion or infection)
Exclusion criteria
✕. Prior history of DVT
✕. Currently receiving an anticoagulant or anti-platelet agents on a daily basis
✕. Diagnosis of high grade malignant brain tumor or metastasis to the brain
✕. Clinical signs/symptoms of DVT
✕. Clinical signs/symptoms of Pulmonary embolism
What they're measuring
1
Composite Endpoint for Arm B of the Study: Catheter Removal, Signs and Symptoms of DVT or PE, OR Bacteremia/Fungemia
Timeframe: 16 weeks
Trial details
NCT IDNCT00633061
SponsorUniversity of Texas Southwestern Medical Center