Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism

NCT ID: NCT04790370

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 544 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-02
• Study Completion Date: 2026-08-31

Brief Summary

There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE.

Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.

Detailed Description

This study will assess whether ultrasound-facilitated, catheter-directed thrombolysis and standard anticoagulation are associated with a significant reduction in the composite outcome of pulmonary embolism (PE)-related mortality, cardiorespiratory decompensation or collapse, or nonfatal symptomatic and objectively confirmed recurrence of PE compared to anticoagulation alone within seven days of randomization

The HI-PEITHO study has been designed to address the important gaps in clinical evidence by comparing the clinical benefit of the ultrasound-facilitated local delivery of a low dose thrombolytic agent and anticoagulation with those of anticoagulation alone in patients with intermediate-high risk PE at a higher estimated risk of early decompensation based on clinical parameters at presentation.

This study has a focus on improving the safety of thrombolysis and advancing the concept of intermediate-high risk and the PE severity criteria, to better identify patients who may clinically benefit from thrombolysis.

The results of this study will contribute further evidence to the existing data on the treatment and outcomes of acute, intermediate-high risk PE and provide controlled data related to catheter-based interventions.

Data will be entered by the site into an electronic database. The database will include data checks to compare data entered into the database against predefined rules for ranges and consistency with other data fields in the database.

Site monitoring will take place with source data verification to assess the accuracy and completeness of registry data by comparing the data to medical records and study assessments.

Conditions

Pulmonary Embolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Anticoagulation

Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH)

Group Type: ACTIVE_COMPARATOR

Anticoagulation with heparin

Intervention Type: DRUG

Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH)

Anticoagulation and EkoSonicTM Endovascular System

Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH) and EkoSonicTM Endovascular System \[ultrasound-facilitated catheter-directed delivery of thrombolytic: 2 mg bolus/catheter + 1 mg/hour/catheter for 7 hours (total of 9 or 18 mg\]

Group Type: ACTIVE_COMPARATOR

Anticoagulation with heparin

Intervention Type: DRUG

Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH)

EkoSonicTM Endovascular System

Intervention Type: DEVICE

EkoSonicTM Endovascular System \[ultrasound-facilitated catheter-directed delivery of thrombolytic: 2 mg bolus/catheter + 1 mg/hour/catheter for 7 hours (total of 9 or 18 mg\]

Interventions

Anticoagulation with heparin

Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH)

Intervention Type: DRUG

EkoSonicTM Endovascular System

EkoSonicTM Endovascular System \[ultrasound-facilitated catheter-directed delivery of thrombolytic: 2 mg bolus/catheter + 1 mg/hour/catheter for 7 hours (total of 9 or 18 mg\]

Intervention Type: DEVICE

Other Intervention Names

heparin, LMWH, UFH, anticoag, antiplatelet; EKOS, USCDT, CDT, thrombolysis, fibrinolysis

Eligibility Criteria

Inclusion Criteria

• Age 18-80 years, inclusive
• Objectively confirmed acute PE, based on computed tomography pulmonary angiography (CTPA) showing a filling defect in at least one main or proximal lobar pulmonary artery
• Elevated risk of early death/hemodynamic collapse, indicated by at least two of the following new-onset clinical criteria:

1. ECG-documented tachycardia with heart rate ≥100 beats per minute, not due to hypovolemia, arrhythmia, or sepsis;

2. SBP ≤ 110 mm Hg for at least 15 minutes;

3. respiratory rate > 20 x min^-1 or oxygen saturation on pulse oximetry (SpO2) < 90% (or partial arterial oxygen pressure < 60 mmHg) at rest while breathing room air;

• Right-to-left ventricular (RV/LV) diameter ratio ≥ 1.0 on CTPA
• Serum troponin I or T levels above the upper limit of normal
• Signed informed consent

Exclusion Criteria

• Hemodynamic instability*, i.e. at least one of the following present:

1. cardiac arrest or need for cardiopulmonary resuscitation;

2. need for ECMO, or ECMO initiated before randomization

3. PE-related shock, defined as: (i) SBP < 90 mmHg, or vasopressors required to achieve SBP ≥ 90 mmHg, despite an adequate volume status; and (ii) end-organ hypoperfusion (altered mental status; oliguria/anuria; increased serum lactate);

4. isolated persistent hypotension (SBP < 90 mmHg, or a systolic pressure drop by at least 40 mmHg for at least 15 minutes), not caused by new-onset arrhythmia, hypovolemia, or sepsis * Patients who presented with temporary need for fluid resuscitation and/or low-dose catecholamines may be included, provided that they could be stabilized within 2 hours of admission and maintain SBP of ≥ 90 mmHg and adequate organ perfusion without catecholamine infusion.

• Need for admission to an intensive care unit for a reason other than the index PE episode. NB: Patients who test positive for SARS-CoV-2 can be enrolled where the investigator believes that the pulmonary embolism is the dominant pathology in the patient's clinical presentation and qualifying cardiorespiratory parameters.
• Temperature above 39 degrees C / 102.2 degrees F
• Logistical reasons limiting the rapid availability of interventional procedures to treat acute PE (e.g., during the outbreak of an epidemic)
• Index PE symptom duration > 14 days
• Active bleeding
• History of intracranial or intraocular bleeding at any time
• Stroke or transient ischemic attack within the past 6 months, or previous stroke at any time if associated with permanent disability
• Central nervous system neoplasm, or metastatic cancer
• Major neurologic, ophthalmologic, abdominal, cardiac, thoracic, vascular or orthopedic surgery or trauma (including syncope-associated with head strike or skeletal fracture) within the past 3 weeks
• Platelet count < 100 x 10^9 x L^-1
• Patients who have received a once-daily therapeutic dose of LMWH or a therapeutic dose of fondaparinux within 24 hours prior to randomization
• Patients who have received one of the direct oral anticoagulants apixaban or rivaroxaban within 12 hours prior to randomization
• Patients who have received one of the direct oral anticoagulants dabigatran or edoxaban for the index PE episode, as these drugs are not approved for patients who have not received heparin for at least 5 days
• Administration of a thrombolytic agent or a glycoprotein IIb/IIIa receptor antagonist during the current hospital stay and/or within 30 days, for any reason
• Chronic treatment with antiplatelet agents other than low-dose acetylsalicylic acid or clopidogrel 75 mg once daily (but not both). Dual antiplatelet therapy is excluded.
• Chronic treatment with a direct oral anticoagulant (apixaban, dabigatran, edoxaban or rivaroxaban)
• Chronic treatment with a vitamin K antagonist, or known coagulopathy including severe hepatic dysfunction, with an International Normalized Ratio (INR) > 1.5
• Pregnancy or lactation
• Previous inclusion in the study
• Known hypersensitivity to alteplase, LMWH or UFH, or to any of the excipients
• Life expectancy less than 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National PERT Consortium, Inc.

UNKNOWN

Sponsor Role: collaborator

University Medical Center Mainz

OTHER

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stavros Konstantinides, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Mainz, Mainz, Germany

Kenneth Rosenfield, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital, Boston, Massachusetts, USA

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Cedars - Sinai Medical Center

Los Angeles, California, United States

Christiana Hospital

Newark, Delaware, United States

Piedmont Hospital

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Augusta University

Augusta, Georgia, United States

Methodist Hospitals

Merrillville, Indiana, United States

Jewish Hospital

Louisville, Kentucky, United States

Baptist Health East Louisville

Lousville, Kentucky, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan Hospitals

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Cooper Hospital - University Medical Center

Camden, New Jersey, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Mount Sinai Medical Center

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

University Hospitals of Cleveland

Cleveland, Ohio, United States

Kettering Health

Kettering, Ohio, United States

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Seton Medical Center

Austin, Texas, United States

Houston Methodist Sugarland Hospital

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

University of Wisconsin Hospitals

Madison, Wisconsin, United States

A.o. LKH Univ.-Kliniken Innsbruck

Innsbruck, , Austria

Universitätsklinikum St. Pölten

Sankt Pölten, , Austria

Allgemeines Krankenhaus AKH

Vienna, , Austria

Austria Klinik Ottakring Vienna

Vienna, , Austria

CHU de Besancon

Besançon, , France

CHU (Nimes Cedex)

Nîmes, , France

Hôpital Européen Georges Pompidou (HEGP)

Paris, , France

Uniklinik Aachen

Aachen, , Germany

Klinikum Bielefeld

Bielefeld, , Germany

GFO Kliniken Bonn

Bonn, , Germany

Klinikum Chemnitz

Chemnitz, , Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, , Germany

Klinik Immenstadt

Immenstädt, , Germany

Universitaetsklinikum Schleswig-Holstein

Lübeck, , Germany

Johannes Gutenberg Universitaet Mainz

Mainz, , Germany

Klinikum Rechts der Isar

Munich, , Germany

Universitaetsklinikum Tuebingen

Tübingen, , Germany

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Mater Misericordiae University Hospital

Dublin, , Ireland

University Hospital Galway

Galway, , Ireland

Leiden University Medical Center

Leiden, , Netherlands

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Universitair Medisch Centrum

Utrecht, , Netherlands

John Paul II Hospital

Krakow, , Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, , Poland

Medical University of Warsaw

Warsaw, , Poland

University Hospital Basel

Basel, , Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

University Hospital Zurich

Zurich, , Switzerland

University Hospital of Wales

Cardiff, , United Kingdom

The Royal Free Hospital

London, , United Kingdom

Northwick Park Hospital

Middlesex, , United Kingdom

Countries

United States; Austria; France; Germany; Ireland; Netherlands; Poland; Switzerland; United Kingdom

References

Barco S, Vicaut E, Klok FA, Lankeit M, Meyer G, Konstantinides SV; PEITHO Investigators. Improved identification of thrombolysis candidates amongst intermediate-risk pulmonary embolism patients: implications for future trials. Eur Respir J. 2018 Jan 18;51(1):1701775. doi: 10.1183/13993003.01775-2017. Print 2018 Jan. No abstract available.

Reference Type: BACKGROUND

PMID: 29348184 (View on PubMed)

Marti C, John G, Konstantinides S, Combescure C, Sanchez O, Lankeit M, Meyer G, Perrier A. Systemic thrombolytic therapy for acute pulmonary embolism: a systematic review and meta-analysis. Eur Heart J. 2015 Mar 7;36(10):605-14. doi: 10.1093/eurheartj/ehu218. Epub 2014 Jun 10.

Reference Type: BACKGROUND

PMID: 24917641 (View on PubMed)

Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7.

Reference Type: BACKGROUND

PMID: 26867832 (View on PubMed)

Jaff MR, McMurtry MS, Archer SL, Cushman M, Goldenberg N, Goldhaber SZ, Jenkins JS, Kline JA, Michaels AD, Thistlethwaite P, Vedantham S, White RJ, Zierler BK; American Heart Association Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; American Heart Association Council on Peripheral Vascular Disease; American Heart Association Council on Arteriosclerosis, Thrombosis and Vascular Biology. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation. 2011 Apr 26;123(16):1788-830. doi: 10.1161/CIR.0b013e318214914f. Epub 2011 Mar 21.

Reference Type: BACKGROUND

PMID: 21422387 (View on PubMed)

Becattini C, Agnelli G, Lankeit M, Masotti L, Pruszczyk P, Casazza F, Vanni S, Nitti C, Kamphuisen P, Vedovati MC, De Natale MG, Konstantinides S. Acute pulmonary embolism: mortality prediction by the 2014 European Society of Cardiology risk stratification model. Eur Respir J. 2016 Sep;48(3):780-6. doi: 10.1183/13993003.00024-2016. Epub 2016 May 12.

Reference Type: BACKGROUND

PMID: 27174887 (View on PubMed)

Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galie N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.

Reference Type: BACKGROUND

PMID: 24716681 (View on PubMed)

Bajaj NS, Kalra R, Arora P, Ather S, Guichard JL, Lancaster WJ, Patel N, Raman F, Arora G, Al Solaiman F, Clark DT 3rd, Dell'Italia LJ, Leesar MA, Davies JE, McGiffin DC, Ahmed MI. Catheter-directed treatment for acute pulmonary embolism: Systematic review and single-arm meta-analyses. Int J Cardiol. 2016 Dec 15;225:128-139. doi: 10.1016/j.ijcard.2016.09.036. Epub 2016 Sep 20.

Reference Type: BACKGROUND

PMID: 27718446 (View on PubMed)

Kucher N, Boekstegers P, Muller OJ, Kupatt C, Beyer-Westendorf J, Heitzer T, Tebbe U, Horstkotte J, Muller R, Blessing E, Greif M, Lange P, Hoffmann RT, Werth S, Barmeyer A, Hartel D, Grunwald H, Empen K, Baumgartner I. Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. Circulation. 2014 Jan 28;129(4):479-86. doi: 10.1161/CIRCULATIONAHA.113.005544. Epub 2013 Nov 13.

Reference Type: BACKGROUND

PMID: 24226805 (View on PubMed)

Piazza G, Hohlfelder B, Jaff MR, Ouriel K, Engelhardt TC, Sterling KM, Jones NJ, Gurley JC, Bhatheja R, Kennedy RJ, Goswami N, Natarajan K, Rundback J, Sadiq IR, Liu SK, Bhalla N, Raja ML, Weinstock BS, Cynamon J, Elmasri FF, Garcia MJ, Kumar M, Ayerdi J, Soukas P, Kuo W, Liu PY, Goldhaber SZ; SEATTLE II Investigators. A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-1392. doi: 10.1016/j.jcin.2015.04.020.

Reference Type: BACKGROUND

PMID: 26315743 (View on PubMed)

Kuo WT, Banerjee A, Kim PS, DeMarco FJ Jr, Levy JR, Facchini FR, Unver K, Bertini MJ, Sista AK, Hall MJ, Rosenberg JK, De Gregorio MA. Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry. Chest. 2015 Sep;148(3):667-673. doi: 10.1378/chest.15-0119.

Reference Type: BACKGROUND

PMID: 25856269 (View on PubMed)

Tapson VF, Sterling K, Jones N, Elder M, Tripathy U, Brower J, Maholic RL, Ross CB, Natarajan K, Fong P, Greenspon L, Tamaddon H, Piracha AR, Engelhardt T, Katopodis J, Marques V, Sharp ASP, Piazza G, Goldhaber SZ. A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: The OPTALYSE PE Trial. JACC Cardiovasc Interv. 2018 Jul 23;11(14):1401-1410. doi: 10.1016/j.jcin.2018.04.008.

Reference Type: BACKGROUND

PMID: 30025734 (View on PubMed)

Steering Committee. Single-bolus tenecteplase plus heparin compared with heparin alone for normotensive patients with acute pulmonary embolism who have evidence of right ventricular dysfunction and myocardial injury: rationale and design of the Pulmonary Embolism Thrombolysis (PEITHO) trial. Am Heart J. 2012 Jan;163(1):33-38.e1. doi: 10.1016/j.ahj.2011.10.003.

Reference Type: BACKGROUND

PMID: 22172434 (View on PubMed)

Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

Reference Type: BACKGROUND

PMID: 21670242 (View on PubMed)

GUSTO investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993 Sep 2;329(10):673-82. doi: 10.1056/NEJM199309023291001.

Reference Type: BACKGROUND

PMID: 8204123 (View on PubMed)

Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.

Reference Type: BACKGROUND

PMID: 15842354 (View on PubMed)

Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.

Reference Type: BACKGROUND

PMID: 20620859 (View on PubMed)

Liu VX, Lu Y, Carey KA, Gilbert ER, Afshar M, Akel M, Shah NS, Dolan J, Winslow C, Kipnis P, Edelson DP, Escobar GJ, Churpek MM. Comparison of Early Warning Scoring Systems for Hospitalized Patients With and Without Infection at Risk for In-Hospital Mortality and Transfer to the Intensive Care Unit. JAMA Netw Open. 2020 May 1;3(5):e205191. doi: 10.1001/jamanetworkopen.2020.5191.

Reference Type: BACKGROUND

PMID: 32427324 (View on PubMed)

Smith GB, Prytherch DR, Meredith P, Schmidt PE, Featherstone PI. The ability of the National Early Warning Score (NEWS) to discriminate patients at risk of early cardiac arrest, unanticipated intensive care unit admission, and death. Resuscitation. 2013 Apr;84(4):465-70. doi: 10.1016/j.resuscitation.2012.12.016. Epub 2013 Jan 4.

Reference Type: BACKGROUND

PMID: 23295778 (View on PubMed)

Quiroz R, Kucher N, Schoepf UJ, Kipfmueller F, Solomon SD, Costello P, Goldhaber SZ. Right ventricular enlargement on chest computed tomography: prognostic role in acute pulmonary embolism. Circulation. 2004 May 25;109(20):2401-4. doi: 10.1161/01.CIR.0000129302.90476.BC. Epub 2004 May 17.

Reference Type: BACKGROUND

PMID: 15148278 (View on PubMed)

Stein PD, Matta F, Yaekoub AY, Goodman LR, Sostman HD, Weg JG, Hales CA, Hull RD, Leeper KV Jr, Beemath A, Saeed IM, Woodard PK. Reconstructed 4-chamber views compared with axial imaging for assessment of right ventricular enlargement on CT pulmonary angiograms. J Thromb Thrombolysis. 2009 Oct;28(3):342-7. doi: 10.1007/s11239-009-0331-5. Epub 2009 Mar 27.

Reference Type: BACKGROUND

PMID: 19326189 (View on PubMed)

ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

Reference Type: BACKGROUND

PMID: 12091180 (View on PubMed)

Klok FA, Cohn DM, Middeldorp S, Scharloo M, Buller HR, van Kralingen KW, Kaptein AA, Huisman MV. Quality of life after pulmonary embolism: validation of the PEmb-QoL Questionnaire. J Thromb Haemost. 2010 Mar;8(3):523-32. doi: 10.1111/j.1538-7836.2009.03726.x. Epub 2009 Dec 15.

Reference Type: BACKGROUND

PMID: 20025645 (View on PubMed)

Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

Reference Type: BACKGROUND

PMID: 1593914 (View on PubMed)

Burnett AE, Mahan CE, Vazquez SR, Oertel LB, Garcia DA, Ansell J. Guidance for the practical management of the direct oral anticoagulants (DOACs) in VTE treatment. J Thromb Thrombolysis. 2016 Jan;41(1):206-32. doi: 10.1007/s11239-015-1310-7.

Reference Type: BACKGROUND

PMID: 26780747 (View on PubMed)

Cech DJ, Martin ST. Evaluation of function, activity, and participation. Functional Movement Development Across the Life Span (Third Edition), 2012.

Reference Type: BACKGROUND

Saris-Baglama RN, Dewey CJ, Chisholm GB, et al. QualityMetric health outcomes™ scoring software 4.0. Lincoln, RI: QualityMetric Incorporated, 2010, p. 138.

Reference Type: BACKGROUND

Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.

Reference Type: BACKGROUND

PMID: 31504429 (View on PubMed)

Klok FA, Piazza G, Sharp ASP, Ni Ainle F, Jaff MR, Chauhan N, Patel B, Barco S, Goldhaber SZ, Kucher N, Lang IM, Schmidtmann I, Sterling KM, Becker D, Martin N, Rosenfield K, Konstantinides SV. Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study. Am Heart J. 2022 Sep;251:43-53. doi: 10.1016/j.ahj.2022.05.011. Epub 2022 May 16.

Reference Type: DERIVED

PMID: 35588898 (View on PubMed)

Other Identifiers

S2479

Identifier Type: -

Identifier Source: org_study_id