Soluble Fibrin for Diagnosing Pulmonary Embolism

NCT02438462 | Completed

• 1 other identifier: SOFIE 2015-A00094-45
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism (PE)

Keywords

Pulmonary Embolism; Soluble Fibrin; D-Dimers; Clinical Probability Score; Imaging

Outcome Measures

Primary Outcomes (1)

• Area under the ROC curve of the Soluble Fibrin for the diagnosis of PE

  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 Outcomes (1)

• Threshold of the Soluble Fibrin assays for the diagnosis of PE

  28 months

Study Arms (2)

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

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

Interventions

Soluble Fibrin OTHER

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 with PE; Group without PE

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 Respiratory and Intensive Care Medicine Units, in a French Hospital.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diagnostica Stago R&D: lead
• European Georges Pompidou Hospital: collaborator

Study Sites (1)

Georges Pompidou European Hospital

Paris, 75908, France

Location

Related Publications (7)

• Roy PM, Colombet I, Durieux P, Chatellier G, Sors H, Meyer G. Systematic review and meta-analysis of strategies for the diagnosis of suspected pulmonary embolism. BMJ. 2005 Jul 30;331(7511):259. doi: 10.1136/bmj.331.7511.259.

  PMID: 16052017 BACKGROUND

• Ginsberg JS, Siragusa S, Douketis J, Johnston M, Moffat K, Donovan D, McGinnis J, Brill-Edwards P, Panju A, Patel A, Weitz JI. Evaluation of a soluble fibrin assay in patients with suspected pulmonary embolism. Thromb Haemost. 1996 Apr;75(4):551-4.

  PMID: 8743176 BACKGROUND

• Hetland O, Knudsen A, Dickstein K, Nilsen DW. Characteristics and prognostic impact of plasma fibrin monomer (soluble fibrin) in patients with coronary artery disease. Blood Coagul Fibrinolysis. 2002 Jun;13(4):301-8. doi: 10.1097/00001721-200206000-00005.

  PMID: 12032395 BACKGROUND

• 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

• Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available.

  PMID: 25173341 BACKGROUND

• Klok FA, Mos IC, Nijkeuter M, Righini M, Perrier A, Le Gal G, Huisman MV. Simplification of the revised Geneva score for assessing clinical probability of pulmonary embolism. Arch Intern Med. 2008 Oct 27;168(19):2131-6. doi: 10.1001/archinte.168.19.2131.

  PMID: 18955643 BACKGROUND

• Righini M, Van Es J, Den Exter PL, Roy PM, Verschuren F, Ghuysen A, Rutschmann OT, Sanchez O, Jaffrelot M, Trinh-Duc A, Le Gall C, Moustafa F, Principe A, Van Houten AA, Ten Wolde M, Douma RA, Hazelaar G, Erkens PM, Van Kralingen KW, Grootenboers MJ, Durian MF, Cheung YW, Meyer G, Bounameaux H, Huisman MV, Kamphuisen PW, Le Gal G. Age-adjusted D-dimer cutoff levels to rule out pulmonary embolism: the ADJUST-PE study. JAMA. 2014 Mar 19;311(11):1117-24. doi: 10.1001/jama.2014.2135.

  PMID: 24643601 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen citrated Poor Platelets Plasma

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

thrombus precursor protein, human

Condition Hierarchy (Ancestors)

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

Study Officials

• Guy Meyer, Ph D

  Georges Pompidou European Hospital

  PRINCIPAL INVESTIGATOR

• Geneviève Contant, Ph D

  Diagnostica Stago R&D

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 8, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

FR (1)