NCT02733198

Prognostication in Acute Pulmonary Embolism

Effect of a Prognostic Algorithm to Reduce Length of Stay in Acute Pulmonary Embolism: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Ministry of Health, Spain · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effect of a prognosis-guided vs standard medical therapy in the: 1) duration of hospital stay; 2) cost-effectiveness; 3) satisfaction and quality of life; 4) in-hospital and 30-day all-cause mortality; and 5) 30-day readmissions in normotensive patients with acute symptomatic pulmonary embolism (PE). Design: Prospective, randomized, controlled, single blind trial. Normotensive patients with acute symptomatic PE will be randomly assigned to follow a prognosis-guided treatment, or to receive usual care. Setting: Respiratory, Medicine and Emergency Departments in 15 Spanish hospitals. Analyses: Data for the primary and secondary end points will be analyzed according to the intention-to -treat principle. The intention-to-treat analysis will include all randomly assigned patients. For the efficacy end points, investigators will use the Mann-Whitney U test. We will also use competing risk regression models according to Fine and Gray. For the safety end points, comparisons will be made with the use of the chi-square test. Separate analyses will be done in key prespecified subgroups of patients, according to age and hospital size.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
OTHER	Prognosis-guided therapy

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2016-04-11
• Last updated: 2019-11-18

Locations

1 site across 1 country: Spain