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| Name | Class |
|---|---|
| American College of Chest Physicians | OTHER |
| Sociedad Española de NeumologÃa y CirugÃa Torácica | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard management | No Intervention | All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT). | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90-day follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | All-cause mortality. | 90-day follow-up |
| Symptomatic Recurrent Venous Thromboembolism | Symptomatic venous thromboembolic recurrence confirmed by objective testing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Jimenez, MD, PhD | IRYCIS, Alcala de Henares University | Study Chair |
| Alvar Agusti, MD, PhD | Hospital Clinic | Study Chair |
| Manuel Monreal, MD, PhD | Germans Trias i Pujol Hospital | Study Chair |
| Remedios Otero, MD, PhD | Hospital Virgen del Rocio | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Barcelona | Spain | |||
| Hospital La Coruña |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18448019 | Background | 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. | |
| 17507545 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Search for Pulmonary Embolism | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 3, 2018 | Dec 9, 2021 |
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|
| 90-day follow-up |
| Hospitalization | Need for readmission. | 90-day follow-up |
| Major Bleeding | Major bleeding (defined according to previously published criteria) | 90-day follow-up |
| Clinically Relevant Non Major Bleeding | Clinically relevant non major bleeding (defined according to previously published criteria) | 90-day follow-up |
| Serious Adverse Events | Serious adverse events. | 90-day follow-up |
| A Coruña |
| Spain |
| Hospital Galdakao | Barakaldo | Spain |
| Clinica Nostra Senyora del Remei | Barcelona | Spain |
| Hospital Capio Sagrat Cor | Barcelona | Spain |
| Hospital Cruces | Bilbao | Spain |
| Hospital San Pedro | Logroño | Spain |
| Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University | Madrid | 28034 | Spain |
| Fundacion Jimenez Diaz | Madrid | Spain |
| Hospital Alcorcon | Madrid | Spain |
| Hospital Doce de Octubre | Madrid | Spain |
| Hospital Gregorio Marañon | Madrid | Spain |
| Hospital La Paz | Madrid | Spain |
| Complejo Hospitalario Pontevedra | Pontevedra | Spain |
| Hospital Marques de Valdecilla | Santander | Spain |
| Policlinico La Rosaleda | Santiago de Compostela | Spain |
| Hospital Virgen del Rocio | Seville | Spain |
| Hospital Txagorritxu | Vitoria-Gasteiz | Spain |
| Hospital Lozano Blesa | Zaragoza | Spain |
| Background |
| Rabe 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. |
| Background | Camargo CA Jr, Roberts J, Clark S. US emergency department visits for COPD exacerbations between 1992 and 1998. Am J Epidemiol 2001; 153: S80. |
| 11489063 | Background | 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. |
| 16549851 | Background | Tillie-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. |
| 18812453 | Background | Rizkallah 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. |
| 18165667 | Background | Anderson 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. |
| 22315268 | Background | Kearon 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. |
| 22911875 | Background | Pozo-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. |
| 37988846 | Derived | Najarro 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. |
| 37327883 | Derived | Rodriguez 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. |
| 36708691 | Derived | Mirambeaux 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. |
| 35241119 | Derived | Rodriguez 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. |
| 34609451 | Derived | Jimenez 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. |
| 30706520 | Derived | Jimenez 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. |
| FG001 | Standard Management | All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Search for Pulmonary Embolism | 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. 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. |
| BG001 | Standard Management | All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 90-day follow-up |
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| Secondary | All-cause Mortality | All-cause mortality. | Posted | Number | participants | 90-day follow-up |
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| Secondary | Symptomatic Recurrent Venous Thromboembolism | Symptomatic venous thromboembolic recurrence confirmed by objective testing. | Posted | Number | participants | 90-day follow-up |
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| Secondary | Hospitalization | Need for readmission. | Posted | Number | participants | 90-day follow-up |
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| Secondary | Major Bleeding | Major bleeding (defined according to previously published criteria) | Posted | Number | participants | 90-day follow-up |
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| Secondary | Clinically Relevant Non Major Bleeding | Clinically relevant non major bleeding (defined according to previously published criteria) | Posted | Number | participants | 90-day follow-up |
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| |||||||||||||||||||||||||||||||
| Secondary | Serious Adverse Events | Serious adverse events. | Posted | Number | participants | 90-day follow-up |
|
|
3 months.
Please see protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Search for Pulmonary Embolism | 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. 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. | 23 | 370 | 18 | 370 | 0 | 370 |
| EG001 | Standard Management | All included patients will undergo standard clinical management of their exacerbations, as deemed appropriate by the attending physician. | 29 | 367 | 18 | 367 | 0 | 367 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SAEs | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Jimenez | Hospital Ramon y Cajal | +34913368133 | djimenez.hrc@gmail.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 3, 2018 | Dec 9, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013923 | Thromboembolism |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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