Pilot Study for assessing Diagnostic Techniques for Central Venous Catheter-related Venous Thromboembolism - CV185-077

Bristol-Myers Squibb0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•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
•5) Males and females from full-term newborns to < 18 years
•6) Women must have a negative serum or urine pregnancy test

•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:
•* Renal function < 50% of normal for age and size
•6) Positive pregnancy test;Allergies and Adverse Drug Reaction
•7) Allergy to gadolinium;Other Exclusion Criteria
•8) Prisoners or subjects who are involuntarily incarcerated
•9) Subjects who are compulsorily detained for treatment of either a psychiatric or
•physical (eg, infectious disease) illness.

发起方

Bristol-Myers Squibb