Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy : HYDRA Study

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Clinically suspected PE as judged by the treating clinician

• Any type of active malignancy (other than basal-cell or squamous-cell carcinoma of the skin), defined as diagnosis within six months before the study inclusion (as confirmed histologically or high suspicion as judged by the clinician), receiving treatment for malignancy at time of inclusion or during 6 months prior to randomization, including recurrent or local metastatic malignancy

• Outpatients and hospitalized patients

• Age ≥ 18 years

• Signed and dated informed consent, available for start of the trial procedure

Locations
Other Locations
Belgium
Antwerpen University Hospital (UZA)
RECRUITING
Antwerp
Cliniques Universitaires Saint-Luc (CUSL)
NOT_YET_RECRUITING
Brussels
Centre Hospitalier Universitaire de Liège (CHU Liège)
NOT_YET_RECRUITING
Liège
France
CHU Brest
RECRUITING
Brest
CHU Clermont-Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
Hôpital Louis Mourier - APHP
NOT_YET_RECRUITING
Colombes
HEGP
NOT_YET_RECRUITING
Paris
CHU Saint-Etienne
RECRUITING
Saint-etienne
Italy
Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda
RECRUITING
Milan
Fondazione Policlinico Universitario A. Gemelli IRCCS
RECRUITING
Roma
Netherlands
Jeroen Bosch Ziekenhuis
ACTIVE_NOT_RECRUITING
's-hertogenbosch
Flevoziekenhuis
RECRUITING
Almere Stad
Amsterdam UMC
RECRUITING
Amsterdam
Rijnstate Ziekenhuis
NOT_YET_RECRUITING
Arnhem
Amphia Ziekenhuis
RECRUITING
Breda
Reinier de Graaf Gasthuis
RECRUITING
Delft
Groene Hart Ziekenhuis
RECRUITING
Gouda
Tergooi MC
RECRUITING
Hilversum
Leiden University Medical Center
RECRUITING
Leiden
Radboud UMC
RECRUITING
Nijmegen
Maasstad Ziekenhuis
RECRUITING
Rotterdam
Haaglanden Medisch Centrum
RECRUITING
The Hague
Bernhoven Ziekenhuis
RECRUITING
Uden
Diakonessenhuis
RECRUITING
Utrecht
Spain
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Switzerland
The Inselspital Bern
RECRUITING
Bern
Hôpitaux Universitaires de Genève (HUG)
RECRUITING
Geneva
Centre Hospitalier Universitaire Vaudois (CHUV)
RECRUITING
Lausanne
Contact Information
Primary
Emily MARTENS, MD
e.s.l.martens@lumc.nl
71-5298096
Backup
Menno HUISMAN, Pr
M.V.Huisman@lumc.nl
Time Frame
Start Date: 2019-06-01
Estimated Completion Date: 2024-05
Participants
Target number of participants: 1566
Treatments
Experimental: YEARS algorithm
Patients randomized to this arm will be evaluated according to the YEARS algorithm.
Active_comparator: CTPA as single test
Patients randomized to this arm will undergo a contrast enhanced CTPA.
Related Therapeutic Areas
Sponsors
Collaborators: Insel Gruppe AG, University Hospital Bern, University Hospital, Antwerp, Leiden University Medical Center
Leads: University Hospital, Brest

This content was sourced from clinicaltrials.gov