Clinical trial NCT02733198: Prognostication in Acute Pulmonary Embolism
Official title: Effect of a Prognostic Algorithm to Reduce Length of Stay in Acute Pulmonary Embolism: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Lead sponsor: Ministry of Health, Spain
Sponsor class: OTHER_GOV
First posted: 2016-04-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay
timeFrame: 30-days
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University
Study officials:
References:
citation: Jimenez D, Rodriguez C, Pintado B, Perez A, Jara-Palomares L, Lopez-Reyes R, Ruiz-Artacho P, Garcia-Ortega A, Bikdeli B, Lobo JL; IPEP investigators. Effect of Prognostic Guided Management of Patients With Acute Pulmonary Embolism According to the European Society of Cardiology Risk Stratification Model. Front Cardiovasc Med. 2022 Apr 12;9:872115. doi: 10.3389/fcvm.2022.872115. eCollection 2022.
citation: Jimenez D, Rodriguez C, Leon F, Jara-Palomares L, Lopez-Reyes R, Ruiz-Artacho P, Elias T, Otero R, Garcia-Ortega A, Rivas-Guerrero A, Abelaira J, Jimenez S, Muriel A, Morillo R, Barrios D, Le Mao R, Yusen RD, Bikdeli B, Monreal M, Lobo JL; IPEP investigators. Randomised controlled trial of a prognostic assessment and management pathway to reduce the length of hospital stay in normotensive patients with acute pulmonary embolism. Eur Respir J. 2022 Feb 10;59(2):2100412. doi: 10.1183/13993003.00412-2021. Print 2022 Feb.