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Clinical Trials/NL-OMON38386
NL-OMON38386
Completed
Phase 2

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

Bristol-Myers Squibb0 sites10 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

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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