Prognostication in Acute Pulmonary Embolism (IPEP)

Ministry of Health, Spain

Status: Completed

Conditions: Pulmonary Embolism

Treatments: Other: Prognosis-guided therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02733198

PI15/00207

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Prognosis-guided

Experimental group

Description:

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

Treatment:

Other: Prognosis-guided therapy

Standard medical therapy

No Intervention group

Description:

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