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

Cancer Clinical Trial

— HYDRA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04657120
• Other study ID #: HYDRA (29BRC20.0087)
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Brest
• Contact: Emily MARTENS, MD
• Phone: 71-5298096
• Email: e.s.l.martens[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1566
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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 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
• contrast allergy Hemodynamic instability at presentation (as a consequence of concurrent acute PE or

otherwise), indicated by at least one of the following:

• systolic blood pressure (SBP) < 100 mm Hg, or heart rate >120 beats per minute or SBP drop by > 40 mm Hg, for > 15 min
• need for catecholamines to maintain adequate organ perfusion and a systolic blood pressure of > 100 mmHg
• Need for cardiopulmonary resuscitation
• Inability to follow-up
• Life expectancy less than 3 months

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Diseases
• Diagnosis
• Embolism
• Embolism and Thrombosis
• Lung Diseases
• Pulmonary Embolism
• Respiratory Tract Diseases
• Thrombosis
• Vascular Diseases

Intervention

Procedure:
• YEARS algorithm
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.
• CTPA
Patients randomized to the CTPA management group will undergo a contrast enhanced CTPA to rule out PE according to standard local practice.

Locations

Country	Name	City	State
Belgium	Antwerpen University Hospital (UZA)	Antwerpen
Belgium	Cliniques Universitaires Saint-Luc (CUSL)	Bruxelles
Belgium	Centre Hospitalier Universitaire de Liège (CHU Liège)	Liège
France	CHU Brest	Brest
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	Hôpital Louis Mourier - APHP	Colombes
France	HEGP	Paris
France	CHU Saint-Etienne	Saint-Étienne
Italy	Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda	Milan
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma
Netherlands	Jeroen Bosch Ziekenhuis	's-Hertogenbosch
Netherlands	Flevoziekenhuis	Almere
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
Spain	Hospital Universitario Ramón y Cajal	Madrid
Switzerland	The Inselspital Bern	Bern
Switzerland	Hôpitaux Universitaires de Genève (HUG)	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Brest	Insel Gruppe AG, University Hospital Bern, Leiden University Medical Center, University Hospital, Antwerp

Countries where clinical trial is conducted

Belgium,  France,  Italy,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent PE	Recurrent PE will be observed	3 months
Primary	Deep vein thrombosis (DVT)	Number of DVT will be observed	3 months
Primary	Mortality	The mortality will be observed	3 months
Secondary	CTPA	Number of performed CTPA will be observed in the YEARS-group at baseline	3 months