Status:
TERMINATED
Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Childhood Cancer
Central Venous Catheters
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief 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 bacte...
Detailed Description
This is a two-part study with an initial diagnosis component followed by a treatment component. The number of subjects to be consented for the diagnosis component is 350, and 50 for the treatment port...
Eligibility Criteria
Inclusion
- 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
- 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
- Renal failure
- Recent major hemorrhage
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00633061
Start Date
June 1 2008
End Date
December 1 2011
Last Update
October 8 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Medical Center
Dallas, Texas, United States, 75235