Prognostication in Acute Pulmonary Embolism
This trial is active, not recruiting.
|Sponsor||Ministry of Health, Spain|
|Start date||April 2016|
|End date||April 2018|
|Trial size||500 participants|
|Trial identifier||NCT02733198, PI15/00207|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Masking||single blind (outcomes assessor)|
Length of hospital stay
time frame: 30-days
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
|Official title||Effect of a Prognostic Algorithm to Reduce Length of Stay in Acute Pulmonary Embolism: a Randomized Controlled Trial|
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