NCT00425542

Brief Summary

The purpose of this randomized clinical trial is to determine whether outpatient treatment is as effective and safe as inpatient treatment among low-risk patients with pulmonary embolism.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
343

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2007

Typical duration for phase_3

Geographic Reach
4 countries

19 active sites

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

Study Start

First participant enrolled

January 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 11, 2010

Status Verified

October 1, 2009

Enrollment Period

3.4 years

First QC Date

January 22, 2007

Last Update Submit

June 10, 2010

Conditions

Pulmonary Embolism

Keywords

Pulmonary embolismOutpatient carePrognosis

Outcome Measures

Primary Outcomes (1)

  • Recurrent, symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism)

    within 3 months of randomization

Secondary Outcomes (4)

  • Major bleeding

    within 3 months of randomization

  • All-cause mortality

    within 3 months of randomization

  • Patient satisfaction with care

    within 2 weeks of randomization

  • Medical resource utilization

    within 3 months of randomization

Study Arms (2)

Outpatient treatment

EXPERIMENTAL
Other: Outpatient care (vs traditional inpatient care)

Inpatient care

NO INTERVENTION

Interventions

Outpatient care (vs traditional inpatient care)OTHER

Patients randomized to the outpatient arm are discharged from the emergency department within 24 hours after randomization. Patients randomized to the inpatient arm are admitted to the hospital and are discharged based on the decision of the managing physician at the hospital.

Also known as: Ambulatory care
Outpatient treatment

Eligibility Criteria

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

You may qualify if:

  • age \>18 years
  • objectively confirmed diagnosis of pulmonary embolism
  • patients at low-risk (Pulmonary Embolism Severity Index score \<=85)

You may not qualify if:

  • patients at high-risk (Pulmonary Embolism Severity Index score \>85)
  • presence of hypoxemia (arterial SO2 \<90% measured by pulse oximetry or an paO2 on room air of \<60 mm Hg measured by blood gas analysis)
  • systolic blood pressure of \<100 mm Hg
  • chest pain necessitating parenteral opioid administration
  • active bleeding or at high-risk of major bleeding (stroke during the preceding 10 days, gastrointestinal bleeding during the preceding 14 days, or platelets \<75,000 per mm3)
  • renal failure (creatinine clearance of \<30 ml/minute based on the Cockcroft-Gault formula)
  • body mass \>150 kg
  • history of HIT or allergy to heparins
  • therapeutic oral anticoagulation (INR ≥2)at the time of pulmonary embolism diagnosis
  • potential barriers to treatment adherence or follow-up (alcoholism, illicit current or recent drug use, psychosis, dementia, homelessness, lack of telephone access, transportation time to nearest ED \>45 minutes)
  • known pregnancy
  • imprisonment
  • diagnosis of pulmonary embolism \>23 hours ago
  • refusal or inability to provide informed consent
  • prior enrollment in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Northwestern Memorial Hospital

Chicago, Illinois, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, United States

Location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Location

University Hospital Saint-Luc, Université Catholique de Louvain

Brussels, 1200, Belgium

Location

University of Leuven

Leuven, 3000, Belgium

Location

University of Angers

Angers, France

Location

University of Argenteuil

Argenteuil, France

Location

University of Boulogne

Boulogne, France

Location

University Hospital of Brest

Brest, France

Location

University of Clermont-Ferrand

Clermont-Ferrand, France

Location

University of Dijon

Dijon, France

Location

University of Nantes

Nantes, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Hôpital Henri Mondor, Créteil

Paris, France

Location

Thiers

Thiers, France

Location

Kantonsspital Baden

Baden, Switzerland

Location

University of Geneva

Geneva, 1211, Switzerland

Location

University Hospital of Lausanne

Lausanne, 1011, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Related Publications (3)

  • Aujesky D, Obrosky DS, Stone RA, Auble TE, Perrier A, Cornuz J, Roy PM, Fine MJ. Derivation and validation of a prognostic model for pulmonary embolism. Am J Respir Crit Care Med. 2005 Oct 15;172(8):1041-6. doi: 10.1164/rccm.200506-862OC. Epub 2005 Jul 14.

    PMID: 16020800BACKGROUND

  • Aujesky D, Roy PM, Le Manach CP, Verschuren F, Meyer G, Obrosky DS, Stone RA, Cornuz J, Fine MJ. Validation of a model to predict adverse outcomes in patients with pulmonary embolism. Eur Heart J. 2006 Feb;27(4):476-81. doi: 10.1093/eurheartj/ehi588. Epub 2005 Oct 5.

    PMID: 16207738BACKGROUND

  • 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: 21703676DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Ambulatory Care

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Drahomir Aujesky, MD, MSc

    University of Lausanne, Switzerland

    PRINCIPAL INVESTIGATOR

  • Donald M Yealy, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2007

First Posted

January 23, 2007

Study Start

January 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 11, 2010

Record last verified: 2009-10

Locations

US(3)FR(10)BE(2)CH(4)