Outpatient Treatment of Low-risk Pulmonary Embolism

NCT02355548 | Completed DMC

• 1 other identifier: 1018558
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is looking at the safety and effectiveness of treating Patients diagnosed with a low-risk Pulmonary Embolism (PE) in an outpatient setting instead of the standard, in-patient hospitalization. Patients have several medical tests done during their Emergency Department visit. Based on those tests, those who are determined to have a low-risk PE are eligible to participate in the study. Those choosing to participate are discharged after 12 hours of medical observation. Patients who choose to participate are followed up by telephone approximately 90 days later.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE

  This is a composite outcome of the above.

  90 Days

Secondary Outcomes (2)

• Reduction of medical costs due to outpatient treatment.

  90 Days

• Level of patient satisfaction as measured by survey.

  90 Days Post study enrollment

Study Arms (1)

Outpatient Treatment

All patients eligible for the study will have their PE treated in the outpatient setting.

Other: Outpatient Treatment of Pulmonary Embolism

Interventions

Outpatient Treatment of Pulmonary Embolism OTHER

Patients who participate in the study will be treated for their pulmonary embolism in an outpatient setting instead of being hospitalized.

Outpatient Treatment

Eligibility Criteria

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

Study Population

The subject population is drawn from patients arriving in the Emergency Department who are then diagnosed with a lower risk pulmonary embolism (PESI score \<86).

You may qualify if:

• Pulmonary Embolism, diagnosed by CTA or high probability VQ Scan
• Total Pulmonary Embolism Severity Index (PESI) score \<86

You may not qualify if:

• Massive Pulmonary Embolism: Hypotension with signs of right heart strain on CTA or Echocardiogram
• Sustained Systolic Blood Pressure (SBP) \<95 mmHg during Emergency Department or observation stay.
• Age \<18
• Pregnant
• Renal insufficiency (Creatinine Clearance \<30)
• Hepatic Dysfunction (AST/ALT/ALP \> 3 times upper limit of normal)
• Unreliable social situation or inability to follow up
• Contraindication to enoxaparin, warfarin and rivaroxaban
• Atrial or ventricular dysrhythmia(s)

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Related Publications (24)

• 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: 16020800 BACKGROUND

• 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: 16207738 BACKGROUND

• Jimenez D, Yusen RD, Otero R, Uresandi F, Nauffal D, Laserna E, Conget F, Oribe M, Cabezudo MA, Diaz G. Prognostic models for selecting patients with acute pulmonary embolism for initial outpatient therapy. Chest. 2007 Jul;132(1):24-30. doi: 10.1378/chest.06-2921.

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• Squizzato A, Ageno W. The 8(th) American College of Chest Physicians Guidelines - a perspective on venous thromboembolism guidelines. Thromb Haemost. 2009 Jan;101(1):31-5. No abstract available.

  PMID: 19132186 BACKGROUND

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  PMID: 18989517 BACKGROUND

• Betriu A, Califf RM, Bosch X, Guerci A, Stebbins AL, Barbagelata NA, Aylward PE, Vahanian A, Van de Werf F, Topol EJ. Recurrent ischemia after thrombolysis: importance of associated clinical findings. GUSTO-I Investigators. Global Utilization of Streptokinase and t-PA [tissue-plasminogen activator] for Occluded Coronary Arteries. J Am Coll Cardiol. 1998 Jan;31(1):94-102. doi: 10.1016/s0735-1097(97)00428-2.

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• Koopman MM, Prandoni P, Piovella F, Ockelford PA, Brandjes DP, van der Meer J, Gallus AS, Simonneau G, Chesterman CH, Prins MH. Treatment of venous thrombosis with intravenous unfractionated heparin administered in the hospital as compared with subcutaneous low-molecular-weight heparin administered at home. The Tasman Study Group. N Engl J Med. 1996 Mar 14;334(11):682-7. doi: 10.1056/NEJM199603143341102.

  PMID: 8594426 BACKGROUND

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  PMID: 11869941 BACKGROUND

• Agnelli G, Verso M, Ageno W, Imberti D, Moia M, Palareti G, Rossi R, Pistelli R; MASTER investigators. The MASTER registry on venous thromboembolism: description of the study cohort. Thromb Res. 2008;121(5):605-10. doi: 10.1016/j.thromres.2007.06.009. Epub 2007 Aug 10.

  PMID: 17692901 BACKGROUND

• Wells PS, Kovacs MJ, Bormanis J, Forgie MA, Goudie D, Morrow B, Kovacs J. Expanding eligibility for outpatient treatment of deep venous thrombosis and pulmonary embolism with low-molecular-weight heparin: a comparison of patient self-injection with homecare injection. Arch Intern Med. 1998 Sep 14;158(16):1809-12. doi: 10.1001/archinte.158.16.1809.

  PMID: 9738611 BACKGROUND

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  PMID: 11057848 BACKGROUND

• Aujesky D, Obrosky DS, Stone RA, Auble TE, Perrier A, Cornuz J, Roy PM, Fine MJ. A prediction rule to identify low-risk patients with pulmonary embolism. Arch Intern Med. 2006 Jan 23;166(2):169-75. doi: 10.1001/archinte.166.2.169.

  PMID: 16432084 BACKGROUND

• Brillman J, Mathers-Dunbar L, Graff L, Joseph T, Leikin JB, Schultz C, Severance HW Jr, Werne C. Management of observation units. American College of Emergency Physicians. Ann Emerg Med. 1995 Jun;25(6):823-30. doi: 10.1016/s0196-0644(95)70215-6. No abstract available.

  PMID: 7755208 BACKGROUND

• Cross E, How S, Goodacre S. Development of acute chest pain services in the UK. Emerg Med J. 2007 Feb;24(2):100-2. doi: 10.1136/emj.2006.043224.

  PMID: 17251613 BACKGROUND

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• Martinez E, Reilly BM, Evans AT, Roberts RR. The observation unit: a new interface between inpatient and outpatient care. Am J Med. 2001 Mar;110(4):274-7. doi: 10.1016/s0002-9343(00)00710-5.

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• Roberts R, Graff LG 4th. Economic issues in observation unit medicine. Emerg Med Clin North Am. 2001 Feb;19(1):19-33. doi: 10.1016/s0733-8627(05)70166-8.

  PMID: 11214399 BACKGROUND

• Goodacre SW. Should we establish chest pain observation units in the UK? A systematic review and critical appraisal of the literature. J Accid Emerg Med. 2000 Jan;17(1):1-6. doi: 10.1136/emj.17.1.1.

  PMID: 10658981 BACKGROUND

• Farkouh ME, Smars PA, Reeder GS, Zinsmeister AR, Evans RW, Meloy TD, Kopecky SL, Allen M, Allison TG, Gibbons RJ, Gabriel SE. A clinical trial of a chest-pain observation unit for patients with unstable angina. Chest Pain Evaluation in the Emergency Room (CHEER) Investigators. N Engl J Med. 1998 Dec 24;339(26):1882-8. doi: 10.1056/NEJM199812243392603.

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• Crenshaw LA, Lindsell CJ, Storrow AB, Lyons MS. An evaluation of emergency physician selection of observation unit patients. Am J Emerg Med. 2006 May;24(3):271-9. doi: 10.1016/j.ajem.2005.11.002.

  PMID: 16635696 BACKGROUND

• Wilkinson K, Severance H. Identification of chest pain patients appropriate for an emergency department observation unit. Emerg Med Clin North Am. 2001 Feb;19(1):35-66. doi: 10.1016/s0733-8627(05)70167-x.

  PMID: 11214403 BACKGROUND

• Dalen JE. Pulmonary embolism: what have we learned since Virchow? Natural history, pathophysiology, and diagnosis. Chest. 2002 Oct;122(4):1440-56. doi: 10.1378/chest.122.4.1440. No abstract available.

  PMID: 12377877 BACKGROUND

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  PMID: 14656907 BACKGROUND

• Bledsoe JR, Woller SC, Stevens SM, Aston V, Patten R, Allen T, Horne BD, Dong L, Lloyd J, Snow G, Madsen T, Elliott CG. Management of Low-Risk Pulmonary Embolism Patients Without Hospitalization: The Low-Risk Pulmonary Embolism Prospective Management Study. Chest. 2018 Aug;154(2):249-256. doi: 10.1016/j.chest.2018.01.035. Epub 2018 Feb 2.

  PMID: 29410163 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

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

Study Officials

• Joseph Bledsoe, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: February 4, 2015
• Study Start: December 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

US (1)