Clinical trial NCT02355548: Outpatient Treatment of Low-risk Pulmonary Embolism
Official title: Rapid Risk Stratification for Outpatient Treatment of Low-risk Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE
timeFrame: 90 Days
Secondary outcomes:
measure: Reduction of medical costs due to outpatient treatment.
timeFrame: 90 Days
measure: Level of patient satisfaction as measured by survey.
timeFrame: 90 Days Post study enrollment
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Joseph Bledsoe, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1164/rccm.200506-862OC. Epub 2005 Jul 14.
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. doi: 10.1093/eurheartj/ehi588. Epub 2005 Oct 5.
citation: 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.
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. No abstract available.
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.
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. doi: 10.1016/s0735-1097(97)00428-2.
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. doi: 10.1056/NEJM199603143341102.
citation: 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.
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. doi: 10.1016/j.thromres.2007.06.009. Epub 2007 Aug 10.
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. doi: 10.1001/archinte.158.16.1809.
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.
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. doi: 10.1001/archinte.166.2.169.
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. doi: 10.1016/s0196-0644(95)70215-6. No abstract available.
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. doi: 10.1136/emj.2006.043224.
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. doi: 10.5694/j.1326-5377.2003.tb05359.x.
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. doi: 10.1016/s0002-9343(00)00710-5.
citation: 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.
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. doi: 10.1136/emj.17.1.1.
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. doi: 10.1056/NEJM199812243392603.
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. doi: 10.1016/j.ajem.2005.11.002.
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. doi: 10.1016/s0733-8627(05)70167-x.
citation: 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.
citation: Goldhaber SZ, Elliott CG. Acute pulmonary embolism: part I: epidemiology, pathophysiology, and diagnosis. Circulation. 2003 Dec 2;108(22):2726-9. doi: 10.1161/01.CIR.0000097829.89204.0C. No abstract available.
citation: 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.