Overview

This trial is active, not recruiting.

Condition pulmonary embolism
Treatment prognosis-guided therapy
Phase phase 3
Sponsor Ministry of Health, Spain
Start date April 2016
End date April 2018
Trial size 500 participants
Trial identifier NCT02733198, PI15/00207

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Duration of bed rest and duration of length of stay will be guided according to a predefined prognostic algorithm.
prognosis-guided therapy
(No Intervention)
Duration of bed rest and duration of length of stay will be decided by the attending physician.

Primary Outcomes

Measure
Length of hospital stay
time frame: 30-days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Confirmed PE by objective testing - Signed and dated informed consent of the subject available before the start of any specific trial procedures Exclusion Criteria: - Pregnancy - Haemodynamic instability - Contraindication to anticoagulant therapy - Life expectancy less than 3 months - Participation in other clinical trials during the present clinical trial - Use of a fibrinolytic agent, surgical thrombectomy, interventional (transcatheter) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE - Inability to the follow-up visits

Additional Information

Official title Effect of a Prognostic Algorithm to Reduce Length of Stay in Acute Pulmonary Embolism: a Randomized Controlled Trial
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Ministry of Health, Spain.