Pulmonary EmbolismLow Risk PENCT02355548
Outpatient Treatment of Low-risk Pulmonary Embolism
An observational study of Pulmonary Embolism, run by Intermountain Health Care, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Outpatient Treatment of Pulmonary Embolism
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Pulmonary Embolism, diagnosed by CTA or high probability VQ Scan
- Total Pulmonary Embolism Severity Index (PESI) score <86
Who cannot join
- 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)
Show all 9Show fewer
- Unreliable social situation or inability to follow up
- Contraindication to enoxaparin, warfarin and rivaroxaban
- Atrial or ventricular dysrhythmia(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Risk Stratification for Outpatient Treatment of Low-risk Pulmonary Embolism
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
- Being tested
- Outpatient Treatment of Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient Treatment of Pulmonary EmbolismOther
Patients who participate in the study will be treated for their pulmonary embolism in an outpatient setting instead of being hospitalized.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Treatment | All patients eligible for the study will have their PE treated in the outpatient setting. Receives: Other: Outpatient Treatment of Pulmonary Embolism |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 Days
Secondary outcomes (2)
Reduction of medical costs due to outpatient treatment.
Measured: 90 Days
Level of patient satisfaction as measured by survey.
Measured: 90 Days Post study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startDec 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Bledsoe, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355548
- Sponsor's protocol ID
- 1018558
- Acronym
- Low Risk PE
- Status last verified
- Nov 2018
- First submitted
- 18 Nov 2014
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16020800Aujesky 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.
PubMed 16207738Jimenez 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.
PubMed 17625081Squizzato 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.
PubMed 19132186Janjua 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.
PubMed 18989517Betriu 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.
PubMed 9426024Koopman 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.
PubMed 8594426Ageno 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.
PubMed 11869941Agnelli 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.
PubMed 17692901Wells 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.
PubMed 9738611Wicki 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.
PubMed 11057848Aujesky 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.
PubMed 16432084Brillman 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.
PubMed 7755208Cross 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.
PubMed 17251613Daly 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.
PubMed 12765504
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Risk Stratification for Outpatient Treatment of Low-risk Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT02355548
- Acronym / sponsor ID
- Low Risk PE / 1018558
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatient Treatment | – | Other: Outpatient Treatment of Pulmonary EmbolismAll patients eligible for the study will have their PE treated in the outpatient setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Pulmonary Embolism, diagnosed by CTA or high probability VQ Scan
- Total Pulmonary Embolism Severity Index (PESI) score <86
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient Treatment of Pulmonary EmbolismPatients who participate in the study will be treated for their pulmonary embolism in an outpatient setting instead of being hospitalized. | Other | Outpatient Treatment |
Primary outcome
90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE
Time frame: 90 Days
This is a composite outcome of the above.
2 secondary outcomes
Reduction of medical costs due to outpatient treatment.
Time frame: 90 Days
Level of patient satisfaction as measured by survey.
Time frame: 90 Days Post study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Background: PubMed 16020800Aujesky 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.
- Background: PubMed 16207738Aujesky 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.
- Background: PubMed 17625081Jimenez 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.
- Background: PubMed 19132186Squizzato 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.
- Background: PubMed 18989517Janjua 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.
- Background: PubMed 9426024Betriu 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.
- Background: PubMed 8594426Koopman 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.
- Background: PubMed 11869941Ageno 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.
- Background: PubMed 17692901Agnelli 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.
- Background: PubMed 9738611Wells 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.
- Background: PubMed 11057848Wicki 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.
- Background: PubMed 16432084Aujesky 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.
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Bledsoe, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02355548, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.