Pulmonary Embolism (PE)SOFIENCT02438462
Soluble Fibrin for Diagnosing Pulmonary Embolism
An observational study of Pulmonary Embolism (PE), run by Diagnostica Stago R&D at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism (PE)
- What is being tested?
- Soluble Fibrin
- How many people
- 480 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients from Emergency or Respiratory and Intensive Care Medicine Units, in a French Hospital.
Who may be able to join
- patients are aged 18 years or older,
- outpatients from Emergency or Respiratory and Intensive Care Medicine Units,
- clinically suspected of PE
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Embolism (PE)
- Being tested
- Soluble Fibrin
- Keywords
- Pulmonary Embolism, Soluble Fibrin, D-Dimers, Clinical Probability Score, Imaging
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble FibrinOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Soluble Fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 months
Secondary outcomes (1)
Threshold of the Soluble Fibrin assays for the diagnosis of PE
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.
Measured: 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Embolism (PE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diagnostica Stago R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Georges Pompidou Hospital
- Responsible party
- Sponsor
- Investigators
- Guy Meyer, Ph D, Principal investigator, Georges Pompidou European HospitalGeneviève Contant, Ph D, Study director, Diagnostica Stago R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438462
- Sponsor's protocol ID
- SOFIE 2015-A00094-45
- Acronym
- SOFIE
- Status last verified
- Apr 2019
- First submitted
- 5 May 2015
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16052017Ginsberg 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.
PubMed 8743176Hetland 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.
PubMed 12032395Mirshahi 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.
PubMed 24664182Konstantinides 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.
PubMed 25173341Klok 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.
PubMed 18955643Righini 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.
PubMed 24643601
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performances of Soluble Fibrin Assay for Diagnosing Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT02438462
- Acronym / sponsor ID
- SOFIE / SOFIE 2015-A00094-45
- Conditions
- Pulmonary Embolism (PE)
- Keywords
- Pulmonary Embolism, Soluble Fibrin, D-Dimers, Clinical Probability Score, Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Diagnostica Stago R&DIndustry (pharma, biotech, devices)
- Collaborators
- European Georges Pompidou Hospital
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with PE | – | Other: Soluble FibrinThe 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 |
| Group without PE | – | Other: Soluble FibrinThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients from Emergency or Respiratory and Intensive Care Medicine Units, in a French Hospital.
Key inclusion criteria (3 listed)
- patients are aged 18 years or older,
- outpatients from Emergency or Respiratory and Intensive Care Medicine Units,
- clinically suspected of PE
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soluble FibrinCalculating the area under the ROC curve of the Soluble Fibrin assay for the diagnosis of PE before evaluating the diagnostic performance of the assay. | Other | Group with PE, Group without PE |
Primary outcome
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.
1 secondary outcome
Threshold of the Soluble Fibrin assays for the diagnosis of PE
Time frame: 28 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Background: PubMed 16052017Roy 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.
- Background: PubMed 8743176Ginsberg 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.
- Background: PubMed 12032395Hetland 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.
- Background: PubMed 24664182Mirshahi 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.
- Background: PubMed 25173341Konstantinides 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.
- Background: PubMed 18955643Klok 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.
- Background: PubMed 24643601Righini 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Embolism (PE)
Not yet recruiting
CTEPH Differential Diagnosis Assisted by Enhanced Large Language Model Support
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)
RecruitingObservational study
A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism
Acute Pulmonary Embolism
Not yet recruiting
Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study
Atrial Fibrillation (AF), Pulmonary Embolism (PE)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Meyer, Ph D principal investigator
Georges Pompidou European Hospital
Geneviève Contant, Ph D study director
Diagnostica Stago R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism (PE), run by Diagnostica Stago R&D at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the ROC curve of the Soluble Fibrin for the diagnosis of PE (time frame: 28 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02438462, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.