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ThRombosis ExclUsion STudy

NCT03477968 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 5935

Last updated 2025-02-25

Study results available
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Summary

Primary objective: To demonstrate the ability of STA® - Liatest® D-Di XL combined with a clinical PreTest Probability (PTP) to safely exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) as measured by Negative Predictive Value (NPV) and sensitivity.

Secondary objectives:

1. To estimate additional STA® - Liatest® D-Di XL accuracy parameters, including specificity and positive predictive value (PPV)
2. To constitute a plasma bank to be used for future studies with other DDi assays under development by Stago.

Conditions

Interventions

DIAGNOSTIC_TEST

DDimer test

Measuring the level of DDimer in blood sample

Sponsors & Collaborators

  • Diagnostica Stago

    lead INDUSTRY

Eligibility

Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-25
Primary Completion
2023-03-29
Completion
2024-09-05
FDA Device
Yes

Countries

  • United States
  • Belgium
  • France
  • Italy
  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03477968 on ClinicalTrials.gov