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Pulmonary EmbolismPhase 4HI-PEITHONCT04790370

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

A Phase 4 study testing Anticoagulation with heparin and EkoSonicTM Endovascular System in people with Pulmonary Embolism, run by Boston Scientific Corporation at 60 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pulmonary Embolism
What is being tested?
Anticoagulation with heparin and EkoSonicTM Endovascular System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
544 participants
Where
60 sitesin 9 countries
Study dates
2 Aug 2021to Aug 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • ECG-documented tachycardia with heart rate ≥100 beats per minute, not due to hypovolemia, arrhythmia, or sepsis;
  • SBP ≤ 110 mm Hg for at least 15 minutes;
  • 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;
Show all 9Show fewer
  • 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

Who cannot join

  • Hemodynamic instability*, i.e. at least one of the following present:
  • cardiac arrest or need for cardiopulmonary resuscitation;
  • need for ECMO, or ECMO initiated before randomization
  • 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);
  • 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.
Show all 26Show fewer
  • 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

Trial locations and contacts

60 sites in 9 countries.

60 sites in 9 countries

United States28 sites

  • University of Michigan Hospitals

    Ann Arbor, Michigan, 48109

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Augusta University

    Augusta, Georgia, 30904

  • Seton Medical Center

    Austin, Texas, 78705

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Houston Methodist Sugarland Hospital

    Houston, Texas, 77479

  • Kettering Health

    Kettering, Ohio, 45429

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37660

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Cedars - Sinai Medical Center

    Los Angeles, California, 90048

  • Baptist Health East Louisville

    Lousville, Kentucky, 40207

  • University of Wisconsin Hospitals

    Madison, Wisconsin, 53792

  • Methodist Hospitals

    Merrillville, Indiana, 46410

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Lenox Hill Hospital

    New York, New York, 10075

  • Christiana Hospital

    Newark, Delaware, 19718

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

Other trials in United States

Germany11 sites

  • Uniklinik Aachen

    Aachen

  • Klinikum Bielefeld

    Bielefeld

  • GFO Kliniken Bonn

    Bonn

  • Klinikum Chemnitz

    Chemnitz

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau

  • Klinik Immenstadt

    Immenstädt

  • Universitaetsklinikum Schleswig-Holstein

    Lübeck

  • Johannes Gutenberg Universitaet Mainz

    Mainz

  • Klinikum Rechts der Isar

    Munich

  • Universitaetsklinikum Tuebingen

    Tübingen

  • Universitaetsklinikum Wuerzburg

    Würzburg

Other trials in Germany

Austria4 sites

  • A.o. LKH Univ.-Kliniken Innsbruck

    Innsbruck

  • Universitätsklinikum St. Pölten

    Sankt Pölten

  • Allgemeines Krankenhaus AKH

    Vienna

  • Austria Klinik Ottakring Vienna

    Vienna

Other trials in Austria

France3 sites

  • CHU de Besancon

    Besançon

  • CHU (Nimes Cedex)

    Nîmes

  • Hôpital Européen Georges Pompidou (HEGP)

    Paris

Other trials in France

Netherlands3 sites

  • Leiden University Medical Center

    Leiden

  • St. Antonius Ziekenhuis

    Nieuwegein

  • Universitair Medisch Centrum

    Utrecht

Other trials in Netherlands

Poland3 sites

  • John Paul II Hospital

    Krakow

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan

  • Medical University of Warsaw

    Warsaw

Other trials in Poland

Switzerland3 sites

  • University Hospital Basel

    Basel

  • Centre Hospitalier Universitaire Vaudois

    Lausanne

  • University Hospital Zurich

    Zurich

Other trials in Switzerland

United Kingdom3 sites

  • University Hospital of Wales

    Cardiff

  • The Royal Free Hospital

    London

  • Northwick Park Hospital

    Middlesex

Other trials in United Kingdom

Ireland2 sites

  • Mater Misericordiae University Hospital

    Dublin

  • University Hospital Galway

    Galway

Other trials in Ireland

About this study

Official title: A Randomized Trial of Ultrasound-facilitated, Catheter-directed, Thrombolysis Versus Anticoagulation for Acute Intermediate-high Risk Pulmonary Embolism: The Higher-risk Pulmonary Embolism Thrombolysis Study

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.

Read the 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.

Being tested
Anticoagulation with heparin, EkoSonicTM Endovascular System
Keywords
Acute intermediate-high risk pulmonary embolism, Ultrasound-facilitated, catheter-directed thrombolysis, Thrombolysis
Medical subject headings
Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anticoagulation with heparinDrug

    Also called heparin, LMWH, UFH, anticoag, antiplatelet

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

  • EkoSonicTM Endovascular SystemDevice

    Also called EKOS, USCDT, CDT, thrombolysis, fibrinolysis

    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]

Study groups in NCT04790370
Study groupRoleWhat they receive
AnticoagulationActive comparatorLow-molecular weight heparin (LMWH) or unfractionated heparin (UFH)
Receives: Drug: Anticoagulation with heparin
Anticoagulation and EkoSonicTM Endovascular SystemActive comparatorLow-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]
Receives: Drug: Anticoagulation with heparin; Device: EkoSonicTM Endovascular System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PE-related mortality

    death resulting from PE

    Measured: Within seven days of randomization

  2. PE recurrence

    nonfatal symptomatic and objectively confirmed recurrence of PE

    Measured: Within seven days of randomization

  3. Cardiorespiratory decompensation or collapse

    Cardiorespiratory collapse or decompensation is defined as at least one of the following criteria:

    1. cardiac arrest or need for CPR at any time between randomization and day 7;
    2. signs of shock: new-onset persistent arterial hypotension (systolic blood pressure (SBP) below 90 mmHg or SBP drop by at least 40 mm Hg, over at least 15 minutes and despite an adequate volume status; or need for vasopressors to maintain SBP of at least 90 mmHg), accompanied by end-organ hypoperfusion (altered mental status; oliguria/anuria; or increased serum lactate) at any time between randomization and day 7;
    3. placement on extracorporeal membrane oxygenation (ECMO) at any time between randomization and day 7;
    4. intubation, or initiation of noninvasive mechanical ventilation at any time between randomization and day 7;
    5. National Early Warning Score (NEWS) of 9 or higher, between 24 hours and 7 days after randomization, confirmed on consecutive measurements taken twice, 15 minutes apart.

    Measured: Within seven days of randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2021
  2. Study start2 Aug 2021
  3. Primary completion31 Jul 2025
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 randomization
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
544 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04790370
Sponsor's protocol ID
S2479
Acronym
HI-PEITHO
Status last verified
Jun 2026
First submitted
2 Mar 2021
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 29348184

  • 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.

    PubMed 24917641

  • 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.

    PubMed 26867832

  • 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.

    PubMed 21422387

  • 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.

    PubMed 27174887

  • 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.

    PubMed 24716681

  • 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.

    PubMed 27718446

  • 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.

    PubMed 24226805

  • 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.

    PubMed 26315743

  • 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.

    PubMed 25856269

  • 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.

    PubMed 30025734

  • 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.

    PubMed 22172434

  • 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.

    PubMed 21670242

  • 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.

    PubMed 8204123

  • 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.

    PubMed 15842354

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anticoagulation with heparin and EkoSonicTM Endovascular System in people with Pulmonary Embolism, run by Boston Scientific Corporation at 60 sites in 9 countries.

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 9 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Germany, Austria, France, Netherlands and 4 more countries. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

PE-related mortality (time frame: Within seven days of randomization). The study lists 3 primary outcomes in all. 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 NCT04790370, which also lists 29 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 1 Jul 2026.

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