Outpatient Treatment of Low-risk Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— Low Risk PE  

Official title:

Rapid Risk Stratification for Outpatient Treatment of Low-risk Pulmonary Embolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355548
• Other study ID #: 1018558
• Status: Completed
• Start date: December 2012
• Est. completion date: December 2017

Study information

• Verified date: November 2018
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Pulmonary Embolism, diagnosed by CTA or high probability VQ Scan

2. Total Pulmonary Embolism Severity Index (PESI) score <86

Exclusion Criteria:

1. Massive Pulmonary Embolism: Hypotension with signs of right heart strain on CTA or Echocardiogram

2. Sustained Systolic Blood Pressure (SBP) <95 mmHg during Emergency Department or observation stay.

3. Age <18

4. Pregnant

5. Renal insufficiency (Creatinine Clearance <30)

6. Hepatic Dysfunction (AST/ALT/ALP > 3 times upper limit of normal)

7. Unreliable social situation or inability to follow up

8. Contraindication to enoxaparin, warfarin and rivaroxaban

9. Atrial or ventricular dysrhythmia(s)

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Other:
• Outpatient Treatment of Pulmonary Embolism
Patients who participate in the study will be treated for their pulmonary embolism in an outpatient setting instead of being hospitalized.

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (23)

Ageno W, Steidl L, Marchesi C, Dentali F, Mera V, Squizzato A, Crowther MA, Venco A. Selecting patients for home treatment of deep vein thrombosis: the problem of cancer. Haematologica. 2002 Mar;87(3):286-91. — View Citation

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. Epub 2007 Aug 10. — View Citation

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. — View Citation

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. Epub 2005 Jul 14. — View Citation

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. Epub 2005 Oct 5. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Cross E, How S, Goodacre S. Development of acute chest pain services in the UK. Emerg Med J. 2007 Feb;24(2):100-2. — View Citation

Dalen JE. Pulmonary embolism: what have we learned since Virchow? Natural history, pathophysiology, and diagnosis. Chest. 2002 Oct;122(4):1440-56. Review. — View Citation

Daly S, Campbell DA, Cameron PA. Short-stay units and observation medicine: a systematic review. Med J Aust. 2003 Jun 2;178(11):559-63. Review. — View Citation

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. — View Citation

Goldhaber SZ, Elliott CG. Acute pulmonary embolism: part I: epidemiology, pathophysiology, and diagnosis. Circulation. 2003 Dec 2;108(22):2726-9. Review. — View Citation

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. Review. — View Citation

Janjua M, Badshah A, Matta F, Danescu LG, Yaekoub AY, Stein PD. Treatment of acute pulmonary embolism as outpatients or following early discharge. A systematic review. Thromb Haemost. 2008 Nov;100(5):756-61. Review. — View Citation

Jiménez D, Yusen RD, Otero R, Uresandi F, Nauffal D, Laserna E, Conget F, Oribe M, Cabezudo MA, Díaz G. Prognostic models for selecting patients with acute pulmonary embolism for initial outpatient therapy. Chest. 2007 Jul;132(1):24-30. — View Citation

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. Erratum in: N Engl J Med 1997 Oct 23;337(17):1251. — View Citation

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. — View Citation

Roberts R, Graff LG 4th. Economic issues in observation unit medicine. Emerg Med Clin North Am. 2001 Feb;19(1):19-33. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Wicki J, Perrier A, Perneger TV, Bounameaux H, Junod AF. Predicting adverse outcome in patients with acute pulmonary embolism: a risk score. Thromb Haemost. 2000 Oct;84(4):548-52. — View Citation

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. Review. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction of medical costs due to outpatient treatment.		90 Days
Secondary	Level of patient satisfaction as measured by survey.		90 Days Post study enrollment