NL-OMON38386
Completed
Phase 2
Pilot Study for assessing Diagnostic Techniques for Central Venous Catheter-related Venous Thromboembolism - CV185-077
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Venous Thromboembolism
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 10
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed Written Informed Consent
- •Target Population
- •2\) Functioning CVC in the upper or lower venous system (eg, jugular, subclavian; femoral vein)
- •3\) Cohort A: Asymptomatic subjects having placement of a new, indwelling CVC in the last 40±20 days
- •4\) Cohort B: Subjects who have experienced symptoms for a CVC\-related DVT with
- •a CVC in place or subjects who have been incidentally identified by radiographic
- •imaging (imaging modalities to diagnose an incidental CVC\-related DVT may
- •include, but is not exclusive of Echocardiogram, CT scan, MRI, or Ultrasound)
- •performed for other clinical reasons, as having a CVC\-related DVT in the veins
- •where the current catheter is placed.;Age and Reproductive Status
Exclusion Criteria
- •1\) Failure to provide written consent from parents or guardians
- •Target Disease Exceptions
- •2\) For cohort A subjects only, present therapeutic dosing of systemic anticoagulant,
- •systemic thromboprophylaxis, or antiplatelet therapy. Local thromboprophylaxis
- •\[flushes, low dose infusions of heparin of up to 5 u/kg/hr or locks with heparin,
- •urokinase, t\-plasminogen activator] according to standard\-of\-care at the respective
- •center will be allowed.;Medical History and Concurrent Diseases
- •3\) Children unable to undergo contrast\-enhanced MRI
- •4\) Pacemaker, osteosynthesis material implanted within the last month;Physical and Laboratory Test Findings
- •5\) Abnormal baseline laboratory test results:
Outcomes
Primary Outcomes
Not specified
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