Soluble Fibrin for Diagnosing Pulmonary Embolism (SOFIE)

April 17, 2019 updated by: Diagnostica Stago R&D

Evaluation of Performances of Soluble Fibrin Assay for Diagnosing Pulmonary Embolism

The purpose of the study is to evaluate the performances of Soluble Fibrin for diagnosing Pulmonary Embolism. Secondary objective is to compare the diagnostic performances of the Soluble Fibrin Assay and the D-Dimer test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale. Pulmonary embolism (PE) is a major public health problem. D-dimer (D-Di) assay is useful to exclude the PE but not specific, requiring irradiating and expensive imaging tests. Preliminary results suggest that the Soluble Fibrin (SF) assay has a sensitivity comparable to the D-Di one, but a higher specificity and thus would limit the use of imaging tests.

Main objective. To compute the area under the ROC curve of the Soluble Fibrin assay for the diagnosis of PE and to assess the other diagnostic characteristics of the SF assay.

Patients. Inclusion criteria: patients 18 years or older, referred to the Emergency or Respiratory and Intensive Care Medicine Units, for clinically suspected of PE.

Exclusion criteria: pregnancy, contraindication to iodinated contrast media, anticoagulant drug at curative doses, patients with suspected PE during hospitalization and those for which the three month-follow up is impossible.

The protocol was approved by the Ethics Committee on March 2015. The study will be conducted in compliance with French regulations after ethics approval.

Reference algorithm. PE has to be confirmed or excluded by the reference algorithm combining clinical probability, D-Dimer, imaging tests and three month-follow up. Plasma D-dimer (D-Di) is measured in case of low clinical probability. Helical computed tomography (CT) is performed in case of either high clinical probability or positive D-dimer. Lower limb venous compression ultrasonography (US) is done only in case of negative CT in a patient with a high clinical probability. Patients will be classified in two groups, as having or not having PE on predefined criteria according to the recent guidelines of the European Society of Cardiology by physicians who will be unaware of the SF assay result.

SF Assays. Soluble fibrin is measured by one site, using prototype assays, on both citrated and heparinized blood samples taken at baseline. Staff in charge of the assays are not aware of the clinical and diagnosis decisions.

Statistical Analysis of results. It will be performed independently by the Clinical Research Unit of Georges Pompidou European Hospital. The ROC curve will be built, the area under the curve will be calculated with its confidence interval. The most suitable threshold will be determined from the curve. Then the diagnostic performances of SF assay will be calculated according to the usual calculations.

Number of participants required. Taking into account an estimated area of 0.9 to 0.95 on preliminary data, the inclusion of 500 patients with suspected PE will allow calculation of the area under the ROC curve with an accuracy of 5%. This number will also allow calculation of the diagnostic performances of the SF assay with sufficient accuracy.

Duration of the study. The study period is three months for each patient, the total duration of the study is 28 months.

Study Type

Observational

Enrollment (Actual)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75908
        • Georges Pompidou European hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatients from Emergency or Respiratory and Intensive Care Medicine Units, in a French Hospital.

Description

Inclusion Criteria:

  • patients are aged 18 years or older,
  • outpatients from Emergency or Respiratory and Intensive Care Medicine Units,
  • clinically suspected of PE

Exclusion Criteria:

  • pregnant women,
  • patients with contraindication to iodinated contrast media,
  • patients treated with anticoagulants at curative doses,
  • patients with suspected PE during hospitalization
  • patients for which the three month-follow up is impossible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group with PE

The criteria for confirmation of PE are:

  • PE on spiral computed tomography (CT)
  • proximal deep vein thrombosis on ultrasound (US)
  • thromboembolic events objectively confirmed during the follow up
Other: Soluble Fibrin
Calculating the area under the ROC curve of the Soluble Fibrin assay for the diagnosis of PE before evaluating the diagnostic performance of the assay.
Group without PE

The criteria for exclusion of PE are:

  • low or moderate clinical probability and D-dimer ELISA <0.50 µg/mL or <10xage in patients older than 50 years and negative follow up
  • low and moderate clinical probability and negative CT and negative follow up
  • high clinical probability and negative CT, US and follow up.
Other: Soluble Fibrin
Calculating the area under the ROC curve of the Soluble Fibrin assay for the diagnosis of PE before evaluating the diagnostic performance of the assay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the ROC curve of the Soluble Fibrin for the diagnosis of PE
Time Frame: 28 months
The ROC curve will be built, the area under the curve will be calculated with its confidence interval. The most suitable threshold will be determined from the curve.
28 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Threshold of the Soluble Fibrin assays for the diagnosis of PE
Time Frame: 28 months
The most suitable threshold will be determined from the curve. Then the diagnosis performances of SF assays will be calculated according to the usual calculations.
28 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diagnostica Stago R&D

Collaborators

European Georges Pompidou Hospital

Investigators

  • Principal Investigator: Guy Meyer, Ph D, Georges Pompidou European hospital
  • Study Director: Geneviève Contant, Ph D, Diagnostica Stago R&D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOFIE 2015-A00094-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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