NCT02733198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

2.8 years

First QC Date

April 5, 2016

Last Update Submit

November 15, 2019

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    30-days

Study Arms (2)

Prognosis-guided

EXPERIMENTAL

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

Other: Prognosis-guided therapy

Standard medical therapy

NO INTERVENTION

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

Interventions

Prognosis-guided therapyOTHER
Prognosis-guided

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed PE by objective testing
  • Signed and dated informed consent of the subject available before the start of any specific trial procedures

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Ramon y Cajal, IRYCIS, Alcala de Henares University

Madrid, 28034, Spain

Location

Related Publications (2)

  • 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.

    PMID: 35497990DERIVED

  • 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.

    PMID: 34385269DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pulmonary physician

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 11, 2016

Study Start

January 1, 2017

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

November 18, 2019

Record last verified: 2019-11

Locations

ES(1)