Hospitalization or Out-treatment ManagEment of Patients With Pulmonary Embolism: a Randomized Controlled Trial

NCT02811237 | Completed DMC

• 1 other identifier: PHRC 2015-04
• Study Type: interventional
• Target: 1,975
• Locations: 5 countries
• Sites: 28

Brief Summary

Several studies have demonstrated the possibility of outpatient management or early discharge for certain patients presenting acute pulmonary embolism (PE), providing a suitable structure is in place. The approach featured in the most recent guidelines on acute PE of the European Society of Cardiology, refers to an all-cause mortality risk assessment using the Pulmonary Embolism Severity Index (PESI) score or the simplified PESI score (sPESI). The sPESI takes into account demographics (age), patient history (cancer, cardiac or respiratory disease), and clinical data (systolic blood pressure, heart rate, oxygen saturation). Outpatient care is offered to low-risk patients, providing that all the conditions pertaining to start anticoagulant treatment and follow-up at home are met. An alternative approach based on a list of simple criteria has been developed as the one used in HESTIA study. The main criteria included in the HESTIA rule consist of absence of the following: hemodynamic instability, need for oxygen therapy, high-risk of hemorrhage, renal or liver failure, or other medical or social conditions requiring hospitalization. The investigators hereby propose comparing these two approaches in an open-label, controlled randomized international trial with blinded adjudication of endpoints. The main objective is to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is at least as safe as regards the 30-day-rate of adverse events (recurrent VTE, major bleeding or death). The major secondary objectives are to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is more effective :

• As regards the rate of patients eventually managed as outpatients.
• As regards the rate of patients, in theory, eligible for outpatient care,

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• The rate of the composite of recurrent VTE, major bleeding and all cause death at 30 days

  * Recurrent VTE: objectively confirmed pulmonary embolism or deep venous thrombosis objectively confirmed. * Major bleeding: according to the International Society on Thrombosis and Haemostasis' criteria. * Death: all-cause mortality.

  30 days

Secondary Outcomes (13)

• The rate of patients actually managed as outpatients (meaning patients discharged home within 24 hours after the inclusion in the study (first major secondary objective))

  1 day

• The rate of "low-risk" patients in theory eligible for outpatient care (second major secondary objective)

  1 day

• Safety endpoints - Rate of cumulative events

  14 days, 30 days, 90 days

• Safety endpoints - Recurrent VTE

  14 days, 30 days, 90 days

• Safety endpoints - Suspected recurrent VTE

  14 days, 30 days, 90 days

Study Arms (2)

HESTIA group

OTHER

Other: HESTIA

sPESI group

OTHER

Other: sPESI

Interventions

HESTIA OTHER

Management based on the HESTIA rule: * If the rule is negative, meaning that patient meet none of the exclusion criteria of the rule, the proposed management will be outpatient care. * In the other cases, the patient will receive in-hospital care. Any reason for management (hospitalization or outpatient treatment) not based on the recommendation will be explained and documented in the e-CRF.

HESTIA group

sPESI OTHER

Management based on the simplified PESI score: * If the sPESI score =0, the proposed management will be outpatient care. * In the other cases, the patient will receive in-hospital care. Any reason for management (hospitalization or outpatient treatment) not based on the recommendation will be explained and documented in the e-CRF.

sPESI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to Emergency Department or unscheduled consultation in one of the participating centres;
• Symptomatic pulmonary embolism objectively confirmed according to the European Society of Cardiology criteria
• Insurance cover according to local legislation;
• Age ≥18 years;
• Free informed consent according to local legislation

You may not qualify if:

• Shock or hypotension defined as systolic blood pressure \<90 mmHg or a systolic pressure drop by ≥40 mmHg, for \>15 minutes, if not caused by new-onset arrhythmia, hypovolaemia, or sepsis;

Sponsors & Collaborators

• University Hospital, Angers: lead
• European Georges Pompidou Hospital: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Leiden University Medical Center: collaborator
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator
• University of Lausanne Hospitals: collaborator

Study Sites (28)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

Hôpital Erasme

Brussels, Belgium

Location

Hôpital Saint-Pierre

Brussels, Belgium

Location

CHU de Liège

Liège, Belgium

Location

Hôpital de Namur

Namur, Belgium

Location

Angers University Hospital

Angers, 49933, France

Location

Hia Brest

Brest, 29240, France

Location

CHU Brest

Brest, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

APHP Louis Mourier

Colombes, France

Location

CHU Dijon

Dijon, France

Location

CHU Grenoble

Grenoble, France

Location

Thibault Schotté

Le Mans, France

Location

CHU de Montpellier

Montpellier, France

Location

APHP Cochin

Paris, France

Location

APHP Hôpital Européen Georges Pompidou

Paris, France

Location

APHP Lariboisière

Paris, France

Location

CHU de Rouen

Rouen, France

Location

CHU Saint Etienne

Saint-Etienne, France

Location

CH Toulon

Toulon, France

Location

CHU Toulouse

Toulouse, France

Location

Red Cross Hospital

Beverwijk, 1942 LE, Netherlands

Location

TERGOOI

Hilversum, 1213 XZ, Netherlands

Location

Leiden University Medical Center Leiden,

Leiden, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Ramon y Cajal Hospital

Madrid, Spain

Location

Hôpital de Genève

Geneva, Switzerland

Location

Hôpital de Lausanne

Lausanne, Switzerland

Location

Related Publications (6)

• Piran S, Le Gal G, Wells PS, Gandara E, Righini M, Rodger MA, Carrier M. Outpatient treatment of symptomatic pulmonary embolism: a systematic review and meta-analysis. Thromb Res. 2013 Nov;132(5):515-9. doi: 10.1016/j.thromres.2013.08.012. Epub 2013 Aug 28.

  PMID: 24035045 BACKGROUND

• Zondag W, Kooiman J, Klok FA, Dekkers OM, Huisman MV. Outpatient versus inpatient treatment in patients with pulmonary embolism: a meta-analysis. Eur Respir J. 2013 Jul;42(1):134-44. doi: 10.1183/09031936.00093712. Epub 2012 Oct 25.

  PMID: 23100493 BACKGROUND

• Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available.

  PMID: 25173341 BACKGROUND

• Aujesky D, Roy PM, Verschuren F, Righini M, Osterwalder J, Egloff M, Renaud B, Verhamme P, Stone RA, Legall C, Sanchez O, Pugh NA, N'gako A, Cornuz J, Hugli O, Beer HJ, Perrier A, Fine MJ, Yealy DM. Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial. Lancet. 2011 Jul 2;378(9785):41-8. doi: 10.1016/S0140-6736(11)60824-6. Epub 2011 Jun 22.

  PMID: 21703676 BACKGROUND

• Zondag W, Mos IC, Creemers-Schild D, Hoogerbrugge AD, Dekkers OM, Dolsma J, Eijsvogel M, Faber LM, Hofstee HM, Hovens MM, Jonkers GJ, van Kralingen KW, Kruip MJ, Vlasveld T, de Vreede MJ, Huisman MV; Hestia Study Investigators. Outpatient treatment in patients with acute pulmonary embolism: the Hestia Study. J Thromb Haemost. 2011 Aug;9(8):1500-7. doi: 10.1111/j.1538-7836.2011.04388.x.

  PMID: 21645235 BACKGROUND

• Roy PM, Penaloza A, Hugli O, Klok FA, Arnoux A, Elias A, Couturaud F, Joly LM, Lopez R, Faber LM, Daoud-Elias M, Planquette B, Bokobza J, Viglino D, Schmidt J, Juchet H, Mahe I, Mulder F, Bartiaux M, Cren R, Moumneh T, Quere I, Falvo N, Montaclair K, Douillet D, Steinier C, Hendriks SV, Benhamou Y, Szwebel TA, Pernod G, Dublanchet N, Lapebie FX, Javaud N, Ghuysen A, Sebbane M, Chatellier G, Meyer G, Jimenez D, Huisman MV, Sanchez O; HOME-PE Study Group. Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial. Eur Heart J. 2021 Aug 31;42(33):3146-3157. doi: 10.1093/eurheartj/ehab373.

  PMID: 34363386 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pierre-Marie ROY, MD.PhD

  CHU d'Angers, France

  PRINCIPAL INVESTIGATOR

• Olivier SANCHEZ, MD.PhD

  APHP Hôpital Européen Georges Pompidou, Paris, France

  PRINCIPAL INVESTIGATOR

• Menno HUISMAN, MD.PhD

  Leiden University Medical Center, Leiden, The Netherlands

  PRINCIPAL INVESTIGATOR

• David JIMENEZ, MD.PhD

  Hospital Universitario Ramon y Cajal, Madrid, Spain

  PRINCIPAL INVESTIGATOR

• Andréa PENALOZA, MD.PhD

  Clinique Unisersitaire Saint Luc, Brussels, Belgium

  PRINCIPAL INVESTIGATOR

• Guy MEYER, MD.PhD

  APHP Hôpital Européen Georges Pompidou, Paris, France

  STUDY CHAIR

• EriK KLOK, MD

  Leiden University Medical Center Leiden, the Netherlands

  PRINCIPAL INVESTIGATOR

• Olivier HUGLI

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 23, 2016
• Study Start: January 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: October 30, 2019
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

NL (4); ES (1); FR (16); CH (2); BE (5)