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

Phase 2

Completed

• Conditions: Venous Thromboembolism; Vein blockage due to clot formation; 10014523

• Registration Number: NL-OMON38386
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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

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:
* 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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified