Deep Vein Thrombosis Clinical Trial
— DVTOfficial title:
Phase II Study on the Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer
Verified date | September 2020 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 136 |
Est. completion date | December 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite Endpoint for Arm B of the Study: Catheter Removal, Signs and Symptoms of DVT or PE, OR Bacteremia/Fungemia | catheter removal, signs and symptoms of DVT or PE, OR bacteremia/fungemia | 16 weeks | |
Secondary | Bleeding Complications Associated With Enoxaparin Therapy, Need for Additional Platelets | Bleeding complications associated with enoxaparin therapy, need for additional platelets | 6 weeks |
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