Prognostication in Acute Pulmonary Embolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Prognosis-guided

Duration of bed rest and duration of length of stay will be guided according to a predefined prognostic algorithm.

Group Type EXPERIMENTAL

Prognosis-guided therapy

Intervention Type OTHER

Standard medical therapy

Duration of bed rest and duration of length of stay will be decided by the attending physician.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prognosis-guided therapy

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No