Pulmonary EmbolismSLICENCT02238639
Pulmonary Embolism as a Cause of COPD Exacerbations
A study testing Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT). in people with Pulmonary Embolism and Chronic Obstructive Pulmonary Disease, run by Ministry of Health, Spain at 19 sites in Spain.
Trial summary
The primary objective is to demonstrate the clinical benefits of an active strategy for the diagnosis and treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who require hospital admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 746 participants
- Where
- 19 sitesSpain
- Study dates
- Oct 2014to Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Confirmation of COPD according to SEPAR-ALT criteria: post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) < 0.7;
- Hospital admission because COPD exacerbation without initial clinical suspicion of PE in the Emergency Department (according by the Emergency Department physician evaluation).
Who cannot join
- Contraindication to multidetector computed tomographic angiography (allergy to intravenous contrast medium, or renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula)
- Informed consent denied
- Pregnancy
- Life expectancy less than 3 months
- Anticoagulant therapy at the time of hospital admission
- Diagnosis of pneumothorax, or pneumonia (fever, and purulent sputum, and new infiltrate in chest X-ray)
Show all 9Show fewer
- Diagnosis of lower respiratory tract infection (fever [>37.8ºC], increased sputum volume and/or increased sputum purulence).
- Indication of invasive mechanical ventilation at the time of hospital admission;
- Impossibility for follow-up.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Spain19 sites
Hospital La Coruña
A Coruña
Hospital Germans Trias i Pujol
Badalona, Barcelona
Hospital Galdakao
Barakaldo
Clinica Nostra Senyora del Remei
Barcelona
Hospital Capio Sagrat Cor
Barcelona
Hospital Cruces
Bilbao
Hospital San Pedro
Logroño
Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University
Madrid, 28034
Fundacion Jimenez Diaz
Madrid
Hospital Alcorcon
Madrid
Hospital Doce de Octubre
Madrid
Hospital Gregorio Marañon
Madrid
Hospital La Paz
Madrid
Complejo Hospitalario Pontevedra
Pontevedra
Hospital Marques de Valdecilla
Santander
Policlinico La Rosaleda
Santiago de Compostela
Hospital Virgen del Rocio
Seville
Hospital Txagorritxu
Vitoria-Gasteiz
Hospital Lozano Blesa
Zaragoza
About this study
Official title: Efficacy and Safety of an Active Strategy for the Diagnosis and Treatment of Acute Pulmonary Embolism (PE) in Patients With Unexplained Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): a Randomized Clinical Trial
The primary objective is to demonstrate the clinical benefits of an active strategy for the diagnosis and treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who require hospital admission.
The secondary objective is to assess the safety of an active strategy for the diagnosis and treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who require hospital admission.
- Being tested
- Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).
- Keywords
- Venous thromboembolism, COPD exacerbations, Anticoagulation, Mortality
- Medical subject headings
- Pulmonary Embolism, Pulmonary Disease, Chronic Obstructive, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).Procedure or surgery
If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines.
If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation.
| Study group | Role | What they receive |
|---|---|---|
| Active search for pulmonary embolism | Experimental | All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed. Receives: Procedure: Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT). |
| Standard management | No intervention | All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.
Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.
Measured: 90-day follow-up
Secondary outcomes (6)
All-cause Mortality
All-cause mortality.
Measured: 90-day follow-up
Symptomatic Recurrent Venous Thromboembolism
Symptomatic venous thromboembolic recurrence confirmed by objective testing.
Measured: 90-day follow-up
Hospitalization
Need for readmission.
Measured: 90-day follow-up
Major Bleeding
Major bleeding (defined according to previously published criteria)
Measured: 90-day follow-up
Clinically Relevant Non Major Bleeding
Clinically relevant non major bleeding (defined according to previously published criteria)
Measured: 90-day follow-up
Serious Adverse Events
Serious adverse events.
Measured: 90-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 746 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Spain
- Sponsor type
- Other government
- Collaborators
- American College of Chest Physicians, Sociedad Española de Neumología y Cirugía Torácica
- Responsible party
- Principal investigator, David Jimenez, Ministry of Health, Spain
- Investigators
- David Jimenez, MD, PhD, Study chair, IRYCIS, Alcala de Henares UniversityAlvar Agusti, MD, PhD, Study chair, Hospital ClinicManuel Monreal, MD, PhD, Study chair, Germans Trias i Pujol HospitalRemedios Otero, MD, PhD, Study chair, Hospital Virgen del Rocio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238639
- Sponsor's protocol ID
- SLICE 1
- Acronym
- SLICE
- Status last verified
- Nov 2022
- First submitted
- 9 Sep 2014
- Last updated
- 1 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Peces-Barba G, Barbera JA, Agusti A, Casanova C, Casas A, Izquierdo JL, Jardim J, Lopez Varela V, Monso E, Montemayor T, Viejo JL. [Diagnosis and management of chronic obstructive pulmonary disease: joint guidelines of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) and the Latin American Thoracic Society (ALAT)]. Arch Bronconeumol. 2008 May;44(5):271-81. No abstract available. Spanish.
PubMed 18448019Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
PubMed 17507545Camargo CA Jr, Roberts J, Clark S. US emergency department visits for COPD exacerbations between 1992 and 1998. Am J Epidemiol 2001; 153: S80.
Poulsen SH, Noer I, Moller JE, Knudsen TE, Frandsen JL. Clinical outcome of patients with suspected pulmonary embolism. A follow-up study of 588 consecutive patients. J Intern Med. 2001 Aug;250(2):137-43. doi: 10.1046/j.1365-2796.2001.00866.x.
PubMed 11489063Tillie-Leblond I, Marquette CH, Perez T, Scherpereel A, Zanetti C, Tonnel AB, Remy-Jardin M. Pulmonary embolism in patients with unexplained exacerbation of chronic obstructive pulmonary disease: prevalence and risk factors. Ann Intern Med. 2006 Mar 21;144(6):390-6. doi: 10.7326/0003-4819-144-6-200603210-00005.
PubMed 16549851Rizkallah J, Man SFP, Sin DD. Prevalence of pulmonary embolism in acute exacerbations of COPD: a systematic review and metaanalysis. Chest. 2009 Mar;135(3):786-793. doi: 10.1378/chest.08-1516. Epub 2008 Sep 23.
PubMed 18812453Anderson DR, Kahn SR, Rodger MA, Kovacs MJ, Morris T, Hirsch A, Lang E, Stiell I, Kovacs G, Dreyer J, Dennie C, Cartier Y, Barnes D, Burton E, Pleasance S, Skedgel C, O'Rouke K, Wells PS. Computed tomographic pulmonary angiography vs ventilation-perfusion lung scanning in patients with suspected pulmonary embolism: a randomized controlled trial. JAMA. 2007 Dec 19;298(23):2743-53. doi: 10.1001/jama.298.23.2743.
PubMed 18165667Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Nelson ME, Wells PS, Gould MK, Dentali F, Crowther M, Kahn SR. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e419S-e496S. doi: 10.1378/chest.11-2301.
PubMed 22315268Pozo-Rodriguez F, Lopez-Campos JL, Alvarez-Martinez CJ, Castro-Acosta A, Aguero R, Hueto J, Hernandez-Hernandez J, Barron M, Abraira V, Forte A, Sanchez Nieto JM, Lopez-Gabaldon E, Cosio BG, Agusti A; AUDIPOC Study Group. Clinical audit of COPD patients requiring hospital admissions in Spain: AUDIPOC study. PLoS One. 2012;7(7):e42156. doi: 10.1371/journal.pone.0042156. Epub 2012 Jul 31.
PubMed 22911875Najarro M, Briceno W, Rodriguez C, Muriel A, Gonzalez S, Castillo A, Jara I, Rali P, Toma C, Bikdeli B, Jimenez D. Shock score for prediction of clinical outcomes among stable patients with acute symptomatic pulmonary embolism. Thromb Res. 2024 Jan;233:18-24. doi: 10.1016/j.thromres.2023.11.011. Epub 2023 Nov 19.
PubMed 37988846Rodriguez C, Muriel A, Carrasco L, Gonzalez S, Briceno W, Duran D, Retegui A, Yusen RD, Bikdeli B, Jimenez D. National Early Warning Score-2 for Identification of Patients with Intermediate-High-Risk Pulmonary Embolism. Semin Thromb Hemost. 2023 Oct;49(7):716-724. doi: 10.1055/s-0043-1769938. Epub 2023 Jun 16.
PubMed 37327883Mirambeaux R, Rodriguez C, Muriel A, Gonzalez S, Briceno W, Duran D, Retegui A, Otero R, Bikdeli B, Jimenez D. Comparison of various prognostic scores for identification of patients with intermediate-high risk pulmonary embolism. Thromb Res. 2023 Mar;223:61-68. doi: 10.1016/j.thromres.2023.01.019. Epub 2023 Jan 23.
PubMed 36708691Rodriguez C, Jara-Palomares L, Tabernero E, Tenes A, Gonzalez S, Briceno W, Lobo JL, Morillo R, Bikdeli B, Jimenez D. Adjusted D-dimer cutoff levels to rule out pulmonary embolism in patients hospitalized for COPD exacerbation: results from the SLICE trial. Thromb J. 2022 Mar 3;20(1):10. doi: 10.1186/s12959-022-00368-0.
PubMed 35241119Jimenez D, Agusti A, Tabernero E, Jara-Palomares L, Hernando A, Ruiz-Artacho P, Perez-Penate G, Rivas-Guerrero A, Rodriguez-Nieto MJ, Ballaz A, Aguero R, Jimenez S, Calle-Rubio M, Lopez-Reyes R, Marcos-Rodriguez P, Barrios D, Rodriguez C, Muriel A, Bertoletti L, Couturaud F, Huisman M, Lobo JL, Yusen RD, Bikdeli B, Monreal M, Otero R; SLICE Trial Group. Effect of a Pulmonary Embolism Diagnostic Strategy on Clinical Outcomes in Patients Hospitalized for COPD Exacerbation: A Randomized Clinical Trial. JAMA. 2021 Oct 5;326(13):1277-1285. doi: 10.1001/jama.2021.14846.
PubMed 34609451Jimenez D, Agusti A, Monreal M, Otero R, Huisman MV, Lobo JL, Quezada A, Jara-Palomares L, Hernando A, Tabernero E, Marcos P, Ruiz-Artacho P, Ballaz A, Bertoletti L, Couturaud F, Yusen R; SLICE investigators. The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy and safety of an active strategy for the diagnosis and treatment of acute pulmonary embolism during exacerbations of chronic obstructive pulmonary disease. Clin Cardiol. 2019 Mar;42(3):346-351. doi: 10.1002/clc.23161. Epub 2019 Feb 25.
PubMed 30706520
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of an Active Strategy for the Diagnosis and Treatment of Acute Pulmonary Embolism (PE) in Patients With Unexplained Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02238639
- Acronym / sponsor ID
- SLICE / SLICE 1
- Keywords
- Venous thromboembolism, COPD exacerbations, Anticoagulation, Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 746 participants (actual)
- Lead sponsor
- Ministry of Health, SpainOther government
- Collaborators
- American College of Chest Physicians, Sociedad Española de Neumología y Cirugía Torácica
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Posted 7 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to demonstrate the clinical benefits of an active strategy for the diagnosis and treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who require hospital admission.
The secondary objective is to assess the safety of an active strategy for the diagnosis and treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who require hospital admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active search for pulmonary embolism | Experimental | Procedure: Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).All included patients will undergo D-dimer testing. A negative plasma highly sensitive D-dimer value (defined as a D-dimer level below the manufacturers assay threshold) will rule out pulmonary embolism, and no further examination will be performed. For patients with a positive D-dimer value, a multidetector computed tomographic pulmonary angiography (MDCT) will be performed. |
| Standard management | No intervention | –All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmation of COPD according to SEPAR-ALT criteria: post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) < 0.7;
- Hospital admission because COPD exacerbation without initial clinical suspicion of PE in the Emergency Department (according by the Emergency Department physician evaluation).
Key exclusion criteria (9 listed)
- Contraindication to multidetector computed tomographic angiography (allergy to intravenous contrast medium, or renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula)
- Informed consent denied
- Pregnancy
- Life expectancy less than 3 months
- Anticoagulant therapy at the time of hospital admission
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 |
|---|---|---|
| Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines. If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation. | Procedure or surgery | Active search for pulmonary embolism |
Primary outcome
All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.
Time frame: 90-day follow-up
Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.
6 secondary outcomes
All-cause Mortality
Time frame: 90-day follow-up
Symptomatic Recurrent Venous Thromboembolism
Time frame: 90-day follow-up
Hospitalization
Time frame: 90-day follow-up
Major Bleeding
Time frame: 90-day follow-up
Clinically Relevant Non Major Bleeding
Time frame: 90-day follow-up
Serious Adverse Events
Time frame: 90-day follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18448019Peces-Barba G, Barbera JA, Agusti A, Casanova C, Casas A, Izquierdo JL, Jardim J, Lopez Varela V, Monso E, Montemayor T, Viejo JL. [Diagnosis and management of chronic obstructive pulmonary disease: joint guidelines of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) and the Latin American Thoracic Society (ALAT)]. Arch Bronconeumol. 2008 May;44(5):271-81. No abstract available. Spanish.
- Background: PubMed 17507545Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
- BackgroundCamargo CA Jr, Roberts J, Clark S. US emergency department visits for COPD exacerbations between 1992 and 1998. Am J Epidemiol 2001; 153: S80.
- Background: PubMed 11489063Poulsen SH, Noer I, Moller JE, Knudsen TE, Frandsen JL. Clinical outcome of patients with suspected pulmonary embolism. A follow-up study of 588 consecutive patients. J Intern Med. 2001 Aug;250(2):137-43. doi: 10.1046/j.1365-2796.2001.00866.x.
- Background: PubMed 16549851Tillie-Leblond I, Marquette CH, Perez T, Scherpereel A, Zanetti C, Tonnel AB, Remy-Jardin M. Pulmonary embolism in patients with unexplained exacerbation of chronic obstructive pulmonary disease: prevalence and risk factors. Ann Intern Med. 2006 Mar 21;144(6):390-6. doi: 10.7326/0003-4819-144-6-200603210-00005.
- Background: PubMed 18812453Rizkallah J, Man SFP, Sin DD. Prevalence of pulmonary embolism in acute exacerbations of COPD: a systematic review and metaanalysis. Chest. 2009 Mar;135(3):786-793. doi: 10.1378/chest.08-1516. Epub 2008 Sep 23.
- Background: PubMed 18165667Anderson DR, Kahn SR, Rodger MA, Kovacs MJ, Morris T, Hirsch A, Lang E, Stiell I, Kovacs G, Dreyer J, Dennie C, Cartier Y, Barnes D, Burton E, Pleasance S, Skedgel C, O'Rouke K, Wells PS. Computed tomographic pulmonary angiography vs ventilation-perfusion lung scanning in patients with suspected pulmonary embolism: a randomized controlled trial. JAMA. 2007 Dec 19;298(23):2743-53. doi: 10.1001/jama.298.23.2743.
- Background: PubMed 22315268Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Nelson ME, Wells PS, Gould MK, Dentali F, Crowther M, Kahn SR. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e419S-e496S. doi: 10.1378/chest.11-2301.
- Background: PubMed 22911875Pozo-Rodriguez F, Lopez-Campos JL, Alvarez-Martinez CJ, Castro-Acosta A, Aguero R, Hueto J, Hernandez-Hernandez J, Barron M, Abraira V, Forte A, Sanchez Nieto JM, Lopez-Gabaldon E, Cosio BG, Agusti A; AUDIPOC Study Group. Clinical audit of COPD patients requiring hospital admissions in Spain: AUDIPOC study. PLoS One. 2012;7(7):e42156. doi: 10.1371/journal.pone.0042156. Epub 2012 Jul 31.
- Derived from this study: PubMed 37988846Najarro M, Briceno W, Rodriguez C, Muriel A, Gonzalez S, Castillo A, Jara I, Rali P, Toma C, Bikdeli B, Jimenez D. Shock score for prediction of clinical outcomes among stable patients with acute symptomatic pulmonary embolism. Thromb Res. 2024 Jan;233:18-24. doi: 10.1016/j.thromres.2023.11.011. Epub 2023 Nov 19.
- Derived from this study: PubMed 37327883Rodriguez C, Muriel A, Carrasco L, Gonzalez S, Briceno W, Duran D, Retegui A, Yusen RD, Bikdeli B, Jimenez D. National Early Warning Score-2 for Identification of Patients with Intermediate-High-Risk Pulmonary Embolism. Semin Thromb Hemost. 2023 Oct;49(7):716-724. doi: 10.1055/s-0043-1769938. Epub 2023 Jun 16.
- Derived from this study: PubMed 36708691Mirambeaux R, Rodriguez C, Muriel A, Gonzalez S, Briceno W, Duran D, Retegui A, Otero R, Bikdeli B, Jimenez D. Comparison of various prognostic scores for identification of patients with intermediate-high risk pulmonary embolism. Thromb Res. 2023 Mar;223:61-68. doi: 10.1016/j.thromres.2023.01.019. Epub 2023 Jan 23.
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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.
David Jimenez, MD, PhD study chair
IRYCIS, Alcala de Henares University
Alvar Agusti, MD, PhD study chair
Hospital Clinic
Manuel Monreal, MD, PhD study chair
Germans Trias i Pujol Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT). in people with Pulmonary Embolism and Chronic Obstructive Pulmonary Disease, run by Ministry of Health, Spain at 19 sites in Spain.
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 2 inclusion and 9 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 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain. 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?
Yes. Results are posted in the registry (first posted 7 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission. (time frame: 90-day follow-up). 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 NCT02238639, which also lists 15 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 1 Dec 2022.