Venous ThromboembolismEXTENDNCT06480994
Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support
An observational study of Venous Thromboembolism and Pulmonary Embolism, run by Diagnostica Stago R&D at 4 sites in France.
Trial summary
The goal of this non interventional study is to demonstrate the diagnostic performances on fresh plasmas in comparison with the performances on frozen plasmas in any patients with VTE suspicion, whatever the pre-test probability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Pulmonary Embolism, Deep Vein Thrombosis
- What is being tested?
- Routine Assays on fresh plasma, New Clinical Decision Support on fresh plasma and New Clinical Decision Support on frozen plasma
- How many people
- 1,836 participants
- Where
- 4 sitesFrance
- Study dates
- 21 Jun 2022to Feb 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
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: * Patients eligible for D-dimer assay, with low or moderate clinical probability, compared to the reference diagnosis (imaging and D-Dimer adjusted and not adjusted for age) * Patients with high clinical probability, compared to the reference diagnosis (imaging) * Patients not eligible for D-dimer assay: either with a condition associated with increased D-dimer levels in the absence of VTE, or with a history of PE or DVT for less than 3 months or suspected thrombotic events * Patients with known and active cancer * Patients with COVID-19
Who may be able to join
- PE and/or DVT suspicion
- No opposition after informing the patient for his participation in research and processing of their data for this purpose,
- Benefiting from the social security system
Who cannot join
- Preventive or curative anticoagulant treatment, or fibrinolytic treatment,
- Legal protection (e.g. guardianship or curatorship),
- Pregnant or breastfeeding women.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon
Cindy Tissier, PhD, +33380295112, cindy.tissier@chu-dijon.fr
Cindy Tissier, PhD
- Recruiting
University Hospital Grenoble
Grenoble
Prudence Mabiala Makele, PhD, +33476766784, pmabialamakele@chu-grenoble.fr
Damien Viglino, PhD
- Recruiting
Centre Hospitalier le Mans
Le Mans, Sartre, 72037
Françoise Rosalie, +33 (0) 243479970, frosalie@ch-lemans.fr
Cyrielle Houalard, PhD
- Recruiting
Centre Hospitalier de Niort
Niort, Sartres, 79021
Diane Chuillet-Moreau, +33 (0) 549782049, Diane.CHUILLET-MOREAU@ch-niort.fr
Angélique Hubert, +33549782428, Angelique.HUBERT@ch-niort.fr
About this study
Official title: Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support With Fresh Plasma, on Any Patient With VTE Suspicion
The goal of this non interventional study is to demonstrate the diagnostic performances on fresh plasmas in comparison with the performances on frozen plasmas in any patients with VTE suspicion, whatever the pre-test probability. The main question it aims to answer is :
Are the performances equivalent on fresh plasmas in comparison with frozen plasmas or is it necessary to determine a new algorithm of the Clinical Decision Support with a new cut-off? Participants will be diagnosed and treated in accordance with routine standard of care.
Read the detailed description
Establish the diagnostic performance of the Clinical Decision Support tool on fresh plasma, in PE and in DVT, in comparison with that on frozen plasma, and in comparison with the current diagnostic strategy, on the entire population and on the following different subpopulations:
- Patients eligible for D-dimer assay, with low or moderate clinical probability, compared to the reference diagnosis (imaging and D-Dimer adjusted and not adjusted for age)
- Patients with high clinical probability, compared to the reference diagnosis (imaging)
- Patients not eligible for D-dimer assay: either with a condition associated with increased D-dimer levels in the absence of VTE, or with a history of PE or DVT for less than 3 months or suspected thrombotic events
- Patients with known and active cancer
- Patients with COVID-19. The assays will be conducted on a fresh and frozen plasma aliquots.
- Being tested
- Routine Assays on fresh plasma, New Clinical Decision Support on fresh plasma, New Clinical Decision Support on frozen plasma
- Medical subject headings
- Venous Thromboembolism, Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Assays on fresh plasmaDiagnostic test
Routine coagulation tests using STA-R Max analyzer :
Prothrombin Time (PT) activated Partial Thromboplastin Time (aPTT Thrombin Time (TT) Fibrinogen Anti-Xa activity
New Clinical Decision Support on fresh plasmaDiagnostic test
D-Dimer and fibrin formation assays on STA-R Max analyzer. Calculation of the exclusion score using an algorithm (manual or based on Machine Learning) compared to a Clinical Decision Support cut-off.
New Clinical Decision Support on frozen plasmaDiagnostic test
D-Dimer and fibrin formation assays on STA-R Max analyzer. Calculation of the exclusion score using an algorithm (manual or based on Machine Learning) compared to a Clinical Decision Support cut-off.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of the new clinical decision support with fresh plasma
Reproducibility (%) calculated with 70% of the study population with fresh plasma in comparison with frozen plasma.
Measured: 37 months
Threshold of the new clinical decision support with fresh plasma
Threshold calculated with 70% of the study population with fresh plasma in comparison with frozen plasma.
Measured: 37 months
PE / DVT sensitivity of the clinical decision support
Sensitivity of the clinical decision support with fresh plasma in comparison with reference diagnosis.
Measured: 48 months
PE / DVT specificity of the clinical decision support
Specificity of the clinical decision support with fresh plasma in comparison with reference diagnosis.
Measured: 48 months
PE / DVT likelihood ratio of the clinical decision support
Likelihood ratio of the clinical decision support with fresh plasma in comparison with reference diagnosis.
Measured: 48 months
PE / DVT exclusion percentage of the clinical decision support
Exclusion percentage of the clinical decision support with fresh plasma in comparison with reference diagnosis.
Measured: 48 months
PE / DVT negative predictive value of the clinical decision support
Negative Predictive Value of the clinical decision support with fresh plasma in comparison with reference diagnosis.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start21 Jun 2022
- Primary completionApr 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies 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
- 1,836 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Diagnostica Stago R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier de Niort, Centre Hospitalier le Mans, Centre Hospitalier Universitaire Dijon, University Hospital, Grenoble
- Responsible party
- Sponsor
- Investigators
- VINCENT VIOLEAU, Principal investigator, Centre Hospitalier de Niort
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480994
- Sponsor's protocol ID
- EXTEND 2021-A03135-36
- Acronym
- EXTEND
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Contant G., Mirshahi S.S., Depasse F., Soria J. A new D-dimer concept for more specific detection of venous thromboembolism. Res Pract Thromb Haemost 2017; 1, (Suppl. 1), PB 1385, Abstracts of the XXVI Congress of the International Society on Thrombosis and Haemostasis, July 8-13, 2017
Planquette B, Jumel S, Pastre J, Pereira H, Marey J, Roche A, Chatellier G, Sanchez O and Meyer G. SOFIE: Soluble Fibrin for Diagnosing Pulmonary Embolism. Res Pract Thromb Haemost 2017; 1, (Suppl. 1), PB 1393, Abstracts of the XXVI Congress of the International Society on Thrombosis and Haemostasis, July 8-13, 2017.
Heit JA, Cohen AT, Anderson FA. Estimated annual number of incident and recurrent, non-fatal and fatal venous thromboembolism (VTE) events in the US. Blood 2005;106(11):910
Cohen AT, Agnelli G, Anderson FA, Arcelus JI, Bergqvist D, Brecht JG, Greer IA, Heit JA, Hutchinson JL, Kakkar AK, Mottier D, Oger E, Samama MM, Spannagl M; VTE Impact Assessment Group in Europe (VITAE). Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007 Oct;98(4):756-64. doi: 10.1160/TH07-03-0212.
PubMed 17938798ISTH Steering Committee for World Thrombosis Day. Thrombosis: a major contributor to the global disease burden. J Thromb Haemost. 2014 Oct;12(10):1580-90. doi: 10.1111/jth.12698.
PubMed 25302663Anderson FA Jr, Spencer FA. Risk factors for venous thromboembolism. Circulation. 2003 Jun 17;107(23 Suppl 1):I9-16. doi: 10.1161/01.CIR.0000078469.07362.E6.
PubMed 12814980Wells PS. Integrated strategies for the diagnosis of venous thromboembolism. J Thromb Haemost. 2007 Jul;5 Suppl 1:41-50. doi: 10.1111/j.1538-7836.2007.02493.x.
PubMed 17635707Wells PS, Anderson DR, Bormanis J, Guy F, Mitchell M, Gray L, Clement C, Robinson KS, Lewandowski B. Value of assessment of pretest probability of deep-vein thrombosis in clinical management. Lancet. 1997 Dec 20-27;350(9094):1795-8. doi: 10.1016/S0140-6736(97)08140-3.
PubMed 9428249Le Gal G, Righini M, Roy PM, Sanchez O, Aujesky D, Bounameaux H, Perrier A. Prediction of pulmonary embolism in the emergency department: the revised Geneva score. Ann Intern Med. 2006 Feb 7;144(3):165-71. doi: 10.7326/0003-4819-144-3-200602070-00004.
PubMed 16461960Schulman S, Ageno W, Konstantinides SV. Venous thromboembolism: Past, present and future. Thromb Haemost. 2017 Jun 28;117(7):1219-1229. doi: 10.1160/TH16-10-0823. Epub 2017 Jun 8.
PubMed 28594049Di Nisio M, Squizzato A, Rutjes AW, Buller HR, Zwinderman AH, Bossuyt PM. Diagnostic accuracy of D-dimer test for exclusion of venous thromboembolism: a systematic review. J Thromb Haemost. 2007 Feb;5(2):296-304. doi: 10.1111/j.1538-7836.2007.02328.x. Epub 2006 Nov 28.
PubMed 17155963Righini M. Is it worth diagnosing and treating distal deep vein thrombosis? No. J Thromb Haemost. 2007 Jul;5 Suppl 1:55-9. doi: 10.1111/j.1538-7836.2007.02468.x.
PubMed 17635709Pawelec G, Goldeck D, Derhovanessian E. Inflammation, ageing and chronic disease. Curr Opin Immunol. 2014 Aug;29:23-8. doi: 10.1016/j.coi.2014.03.007. Epub 2014 Apr 22.
PubMed 24762450Tita-Nwa F, Bos A, Adjei A, Ershler WB, Longo DL, Ferrucci L. Correlates of D-dimer in older persons. Aging Clin Exp Res. 2010 Feb;22(1):20-3. doi: 10.1007/BF03324810.
PubMed 20305364Harper PL, Theakston E, Ahmed J, Ockelford P. D-dimer concentration increases with age reducing the clinical value of the D-dimer assay in the elderly. Intern Med J. 2007 Sep;37(9):607-13. doi: 10.1111/j.1445-5994.2007.01388.x. Epub 2007 Jun 2.
PubMed 17543005