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Prognostication in Acute Pulmonary Embolism

NCT02733198 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2019-11-18

No results posted yet for this study

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

Interventions

OTHER

Prognosis-guided therapy

Sponsors & Collaborators

  • Ministry of Health, Spain

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02733198 on ClinicalTrials.gov