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| Name | Class |
|---|---|
| Insel Gruppe AG, University Hospital Bern | OTHER |
| University Hospital, Antwerp | OTHER |
| University Hospital, Geneva | OTHER |
| Reinier de Graaf Groep |
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The aim of this study is to prospectively validate the safety and efficiency of management according to the YEARS algorithm to safely rule out clinically suspected PE in patients with active malignancy to be compared with 'standard' management by computed tomography pulmonary angiography (CTPA) alone in a randomized study.
Recently, the YEARS-algorithm was demonstrated to be a safe and efficient diagnostic strategy for patients with clinically suspected pulmonary embolism (PE). It is recognized that diagnostic algorithms for pulmonary embolism (PE) may not be as effective and safe in patients with malignancy, due to the low specificity of D-dimer test in that setting. A diagnostic algorithm that could safely rule out PE in patients with malignancy without performing computed tomography pulmonary angiography (CTPA) could nonetheless improve patient care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YEARS algorithm | Experimental | Patients randomized to this arm will be evaluated according to the YEARS algorithm. |
|
| CTPA as single test | Active Comparator | Patients randomized to this arm will undergo a contrast enhanced CTPA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YEARS algorithm | Procedure | Patients randomized to the YEARS algorithm will be evaluated according to the YEARS algorithm consisting of three items of the original Wells rule (clinical signs of DVT, haemoptysis and 'PE most likely diagnosis') and a D-dimer test. In patients without any of the three items and a D-dimer level <1.0 μg/mL (<1000ng/mL), and in patients with ≥1 items and a D-dimer level <0.5 μg/mL (<500 ng/mL) a PE is excluded without CTPA. In the other patients a standard contrast enhanced CTPA will be performed according to local practice. PE is defined as at least one filling defect in the pulmonary artery tree on CTPA. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent PE | Recurrent PE will be observed | 3 months |
| Deep vein thrombosis (DVT) | Number of DVT will be observed | 3 months |
| Mortality | The mortality will be observed Adjudicated according to ISTH definition in which both PE-related death as well as unexplained death will count towards primary outcome | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| CTPA | Number of performed CTPA will be observed in the YEARS-group at baseline | 3 months |
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Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 3 months, or unwillingness to sign informed consent
Treatment with full-dose therapeutically dosed anticoagulation that was initiated 24 hours or more prior to eligibility assessment
Contraindication to CTPA
Hemodynamic instability at presentation (as a consequence of concurrent acute PE or otherwise), indicated by at least one of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Menno Huisman, Pr | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerpen University Hospital (UZA) | Antwerp | Belgium | ||||
| Cliniques Universitaires Saint-Luc (CUSL) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42365759 | Derived | Martens ESL, Akerboom B, Baumgartner C, Brouwer RE, Cavallaro C, Coppens M, Costantino G, Couturaud F, D'Errico A, van Dooren YPA, Gianni F, van der Griend R, Grootenboers MJJH, Hugli O, van der Hulle T, Jaderi Z, Jimenez D, Kamphuisen PW, Lanting VR, Leentjens J, Maas ML, Mahe I, van Meer OA, van Mens TE, Out M, Pola R, Pulver D, Raskin J, Righini M, Sprenger RA, Stals MAM, Talerico R, Tritschler T, Ten Wolde M, Klok FA, Huisman MV; HYDRA study group. Electronic address: research_interne@lumc.nl. A study protocol for a randomised controlled trial evaluating the safety and efficiency of the YEARS algorithm versus computed tomography pulmonary angiography only for suspected acute pulmonary embolism in patients with cancer: the Hydra Study. Thromb Res. 2026 Jun 11;263:109745. doi: 10.1016/j.thromres.2026.109745. Online ahead of print. |
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All collected data that underlie results in a publication
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Data access requests will be reviewed by an internal committee . Requestors will be required to sign and complete a data access agreement.
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| OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| Diakonessenhuis, Utrecht | OTHER |
| Amphia Hospital | OTHER |
| Centre Hospitalier Universitaire Vaudois | OTHER |
| Hospital Universitario Ramon y Cajal | OTHER |
| Tergooi Hospital | OTHER |
| Radboud University Medical Center | OTHER |
| Bernhoven Hospital | OTHER |
| Hôpital Louis Mourier | OTHER |
| Medisch Spectrum Twente | OTHER |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
| Maasstad Hospital | OTHER |
| Flevo Ziekenhuis, Almere | UNKNOWN |
| Groene Hart Ziekenhuis | OTHER |
| University Hospital, Brest | OTHER |
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | OTHER |
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|
| CTPA | Procedure | Patients randomized to the CTPA management group will undergo a contrast enhanced CTPA to rule out PE according to standard local practice. |
|
| Brussels |
| Belgium |
| Centre Hospitalier Universitaire de Liège (CHU Liège) | Liège | Belgium |
| CHU Brest | Brest | 29609 | France |
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| Hôpital Louis Mourier - APHP | Colombes | 92700 | France |
| HEGP | Paris | 75015 | France |
| CHU Saint-Etienne | Saint-Etienne | 42055 | France |
| Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda | Milan | Italy |
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma | Italy |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | Netherlands |
| Flevoziekenhuis | Almere Stad | Netherlands |
| Amsterdam UMC | Amsterdam | Netherlands |
| Rijnstate Ziekenhuis | Arnhem | Netherlands |
| Amphia Ziekenhuis | Breda | Netherlands |
| Reinier de Graaf Gasthuis | Delft | Netherlands |
| Groene Hart Ziekenhuis | Gouda | Netherlands |
| Tergooi MC | Hilversum | Netherlands |
| Leiden University Medical Center | Leiden | Netherlands |
| Radboud UMC | Nijmegen | Netherlands |
| Maasstad Ziekenhuis | Rotterdam | Netherlands |
| Haaglanden Medisch Centrum | The Hague | Netherlands |
| Bernhoven Ziekenhuis | Uden | Netherlands |
| Diakonessenhuis | Utrecht | Netherlands |
| Hospital Universitario Ramón y Cajal | Madrid | Spain |
| The Inselspital Bern | Bern | Switzerland |
| Hôpitaux Universitaires de Genève (HUG) | Geneva | Switzerland |
| Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Switzerland |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009369 | Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C074011 | 4-((1,4,8,11-tetraazacyclotetradec-1-yl)methyl)benzoic acid |
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