NCT04657120

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 698 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.
PROCEDURE	CTPA	Patients randomized to the CTPA management group will undergo a contrast enhanced CTPA to rule out PE according to standard local practice.

Timeline

• Start date: 2019-06-01
• Primary completion: 2025-08-23
• Completion: 2025-08-23
• First posted: 2020-12-08
• Last updated: 2025-12-23

Locations

28 sites across 6 countries: Belgium, France, Italy, Netherlands, Spain, Switzerland