Evaluation of Soluble Fibrin in Thrombosis Exclusion

NCT02523937 | Completed

• 1 other identifier: FSET 2014-A00588-39
• Study Type: observational
• Target: 863
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the performances of Soluble Fibrin assay for exclusion of Pulmonary Embolism and Deep Venous Thrombosis. Secondary objectives are to determine the threshold value from the ROC curves, the possible interest in the positive diagnosis of Venous Thromboembolism (VTE), and to verify the absence of influence of age on the SF results.

Conditions

Pulmonary Embolism (PE); Deep Vein Thrombosis (DVT)

Keywords

Pulmonary Embolism; Deep Venous Thrombosis; Soluble Fibrin; D-Dimers; Low and intermediate clinical probability

Outcome Measures

Primary Outcomes (1)

• Performances of the Soluble Fibrin Assay for the exclusion of PE and DVT

  Determination of the sensitivity and specificity of the Soluble Fibrin Assay to calculate the area under the ROC curve for exclusion of PE and DVT. The most suitable threshold will be determined from the curve.

  24 Months

Secondary Outcomes (1)

• Threshold of the Soluble Fibrin assays for the exclusion of PE and DVT

  24 Months

Study Arms (2)

Group without PE or DVT

PE or DVT have to be confirmed or discarded by combining Wells score clinical probability, D-Dimer, and imaging tests. The criteria for exclusion of PE or DVT are: * low or intermediate clinical probability and D-dimer \<0,50 µg/mL * low and moderate clinical probability and negative spiral computed tomography CT and/or proximal lower limb venous compression ultrasonography (US) * high clinical probability and negative CT and US. Soluble Fibrin assay will be performed in comparison with D-dimer assays.

Other: Soluble Fibrin

Group with PE or DVT

PE or DVT have to be confirmed or discarded by combining Wells score clinical probability, D-Dimer, and imaging tests. The criteria for confirmation of PE or DVT are: * PE on spiral computed tomography (CT) * proximal deep vein thrombosis on ultrasonography (US). Soluble Fibrin assay will be performed in comparison with D-dimer assays.

Other: Soluble Fibrin

Interventions

Soluble Fibrin OTHER

Evaluating the diagnostic performances of the assay in terms of sensitivity, specificity, negative and positive predictive values; from calculation of the area under the curve in comparison with the D-dimers.

Group with PE or DVT; Group without PE or DVT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients from Emergency or Internal Medicine Units, in a French Hospital.

You may qualify if:

• patients with non-opposition to participate in the evaluation,
• outpatients from Emergency or Internal Medicine Units,
• clinically suspected of PE or DVT.

You may not qualify if:

• patients under 18 years old,
• patients with opposition to participate in the evaluation,
• patients with contraindication to iodinated contrast media.

Sponsors & Collaborators

• Diagnostica Stago R&D: lead
• Hôpital Louis Mourier: collaborator
• Hopital Lariboisière: collaborator

Study Sites (1)

Internal Medecine Unit - Adults Pole and Hematology Laboratory Hôpital Louis Mourier (AP-HP)

Colombes, 92701, France

Location

Related Publications (1)

• Mirshahi S, Soria C, Kouchakji B, Kierzek G, Borg JY, Varin R, Chidiac J, Drouet L, Mirshahi M, Soria J. New combinational assay using soluble fibrin and d-dimer determinations: a promising strategy for identifying patients with suspected venous thromboembolism. PLoS One. 2014 Mar 24;9(3):e92379. doi: 10.1371/journal.pone.0092379. eCollection 2014.

  PMID: 24664182 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen heparinized and citrated Poor Platelets Plasma

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis

Interventions

thrombus precursor protein, human

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Study Officials

• Isabelle Mahe, MD, PhD

  Université of Paris 7 - Paris Diderot

  PRINCIPAL INVESTIGATOR

• Geneviève Contant, PhD

  Diagnostica Stago

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 14, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

FR (1)