Prognostication in Acute Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— IPEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733198
• Other study ID #: PI15/00207
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: November 2019

Study information

• Verified date: November 2019
• Source: Ministry of Health, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Other:
• Prognosis-guided therapy

Locations

Country	Name	City	State
Spain	Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay		30-days