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NCT03477968 · ClinicalTrials.gov registry record

ThRombosis ExclUsion STudy

A clinical trial, sponsored by Diagnostica Stago.

Terminated
Registry status
5,935
Enrollment target

NCT03477968: Clinical Trial study, sponsored by Diagnostica Stago.

NCT03477968 is a clinical trial that was terminated before completion, run by Diagnostica Stago. The registered enrollment target is 5,935 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03477968 was terminated before completion, sponsored by Diagnostica Stago.

TERMINATED
Registry status
5,935 participants
Enrollment target

Study 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.

Primary Outcome

According to the ThRombosis ExclUsion STudy (TRUST) protocol, the primary objective of the study was to demonstrate the ability of STA® - Liatest® D-Di XL combined with a clinical PreTest Probability to safely exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) as measured by Negative Predictive Value (NPV) and sensitivity. The first step was to evaluate the stability of the plasmabank using VIDAS system. The preliminary results showed that the plasmabank was unusable with a high r

Interventions

  • DIAGNOSTIC_TEST DDimer test

Trial Details

FieldValue
Enrollment Target 5,935 participants
Start Date 2018-06-25
Est. Completion 2024-09-05
Diagnostica Stago

5 total trials

Why NCT03477968 stopped before completion

NCT03477968 is an observational study that tracks outcomes without assigning an intervention. Its 5,935 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 1 intervention - of which DDimer test is the first listed.

NCT03477968 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03477968 about?

NCT03477968 is a clinical study titled "ThRombosis ExclUsion STudy". 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 estimat...

What is the current status of trial NCT03477968?

This trial is currently terminated. The enrollment target is 5,935 participants. The study started on 2018-06-25. Estimated completion is 2024-09-05.

What interventions are being tested in trial NCT03477968?

The interventions under investigation include: DDimer test (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT03477968?

This trial is sponsored by Diagnostica Stago, which has 5 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03477968, the US trial registry maintained by the National Library of Medicine. NCT03477968 (large enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.