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Catheter-Directed Pulmonary Reperfusion in Treatment of Pulmonary Embolism Patients

Primary Purpose

Pulmonary Embolism

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mechanical fragmentation
In Situ thrombolysis
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring pulmonary embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >18 years old.
  • Both gender males and females.
  • Patients with angiographically confirmed acute high risk pulmonary embolism with shock index >1.
  • pulmonary arterial occlusion with >50% involvement of the central (main and/or lobar) pulmonary, and dysfunction of the right ventricle and elevated troponin.
  • patients with high risk pulmonary embolism who remain unstable after receiving fibrinolysis
  • patients with high risk PE pulmonary embolism who cannot receive fibrinolysis
  • patients with intermediate high risk PE pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV (right ventricle) dysfunction, or major myocardial necrosis)

Exclusion Criteria:

  • patients with echocardiographically confirmed right sided thrombi.
  • patients with low-risk PE pulmonary embolism or submassive acute PE pulmonary embolism with minor RV (right ventricle) dysfunction, minor myocardial necrosis, and no clinical worsening
  • Anaphylactic reaction to contrast media.
  • Acute renal failure or severe chronic non-dialysis dependent kidney disease.
  • Uncooperative patient

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Arm Label

    systemic thrombolysis group

    mechanical fragmentation group

    In Situ thrombolysis group

    Arm Description

    patients without any contraindications for systemic fibrinolytic therapy will be treated with traditional systemic thrombolysis (intravenous administration of streptokinase).

    patients will be treated with catheter-directed mechanical fragmentation under fluoroscopy guidance. This group will include patients with absolute contraindication for fibrinolytic therapy.

    patients will be treated with bed side administration of low dose of local thrombolytic therapy (In Situ) via a trans-Jugular Swan-Ganz pulmonary artery catheter. with guidance of the pressure waveforms obtained from SGC(Swan-Ganz pulmonary artery catheter) and echocardiography guidance for ideal Catheter placement. This group will include the patients with relative contraindications for systemic thrombolysis, contraindications for contrasted administration (patients with renal impairment) and also patients with contraindications for radiation exposure (pregnant women).

    Outcomes

    Primary Outcome Measures

    Rate of mortality (mortality rate)
    number of deaths from total number of patients in each arm
    Rate of complications
    as major and minor bleedings
    Rate of Success
    number of cases with clinical success which defined as stabilization of hemodynamic parameters, resolution of hypoxia, survival from PE(pulmonary embolism) and restoring of right ventricular function (improvement of ghit ventricle and pulmonary artery pressure and decrease troponin level)

    Secondary Outcome Measures

    Percent of Changes in mean blood pressure
    the percent of change in mean arterial blood pressure
    Mean pulmonary artery pressure
    Mean pulmonary artery pressure will be estimated by transthoracic echocardiography
    Duration of ICU(intensive care unit) stay
    the duration of ICU (intensive care unit) stay by days
    Duration of hospital stay
    the duration of hospital stay by days

    Full Information

    First Posted
    May 25, 2021
    Last Updated
    June 14, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04911192
    Brief Title
    Catheter-Directed Pulmonary Reperfusion in Treatment of Pulmonary Embolism Patients
    Official Title
    Catheter-Directed Pulmonary Re Perfusion in Treatment of Intermediate and High Risk Pulmonary Embolism Patients and Its Impact on Pulmonary Artery Pressure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 30, 2021 (Anticipated)
    Primary Completion Date
    June 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Primary objective: to evaluate the success and mortality rates of catheter-directed reperfusion therapy in comparison to traditional use of systemic intravenous fibrinolytic therapy, will focus at safety of such management measured by in-hospital mortality and prevalence of severe adverse events. Secondary objective: to assess the feasibility of catheter-directed reperfusion in management of intermediate and high risk pulmonary embolism in Assiut University hospital and its reflection on pulmonary artery pressure
    Detailed Description
    Venous thromboembolic disease represents one of the most important causes of cardiovascular death in the world. Symptomatic pulmonary embolism (PE) occurs in about 500,000 patients annually, with an estimated mortality as high as 30% in high-risk patients . High-risk pulmonary embolism clinically manifests with hemodynamic instability and systemic hypotension (systolic blood pressure < 90 mm Hg, pressure drop of more than 40 mm Hg or requiring administration of inotropic agents. In this form of PE (pulmonary embolism) imaging studies usually reveal a "saddle embolus" at the bifurcation of the pulmonary trunk, embolism of the main pulmonary artery, or embolic occlusion of at least two lobar arteries. Mortality in high-risk pulmonary embolism is at the level of 60%, and in 66% of these patients fatal outcomes take place during the first hours from the onset of clinical symptoms. The remaining patients with severe pulmonary embolism , those with intermediate risk of mortality, do not reveal hypotension, but present with clinical symptoms comprising dyspnea and/or tachycardia. Estimated 30-day mortality in patients with intermediate risk PE (pulmonary embolism) is at the level of 15-20%, and these patients are at a risk of developing pulmonary hypertension and right ventricle heart failure. Given the fact that 40% of patients with class 4 or 5 of the Pulmonary Embolism Severity Index present with contraindications for systemic fibrinolytic therapy, Catheter-directed reperfusion therapy seems to be a promising alternative treatment modality.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Embolism
    Keywords
    pulmonary embolism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    systemic thrombolysis group
    Arm Type
    No Intervention
    Arm Description
    patients without any contraindications for systemic fibrinolytic therapy will be treated with traditional systemic thrombolysis (intravenous administration of streptokinase).
    Arm Title
    mechanical fragmentation group
    Arm Type
    Active Comparator
    Arm Description
    patients will be treated with catheter-directed mechanical fragmentation under fluoroscopy guidance. This group will include patients with absolute contraindication for fibrinolytic therapy.
    Arm Title
    In Situ thrombolysis group
    Arm Type
    Active Comparator
    Arm Description
    patients will be treated with bed side administration of low dose of local thrombolytic therapy (In Situ) via a trans-Jugular Swan-Ganz pulmonary artery catheter. with guidance of the pressure waveforms obtained from SGC(Swan-Ganz pulmonary artery catheter) and echocardiography guidance for ideal Catheter placement. This group will include the patients with relative contraindications for systemic thrombolysis, contraindications for contrasted administration (patients with renal impairment) and also patients with contraindications for radiation exposure (pregnant women).
    Intervention Type
    Procedure
    Intervention Name(s)
    mechanical fragmentation
    Intervention Description
    patients who will be treated with catheter-directed mechanical fragmentation under fluoroscopy guidance. This group will include patients with absolute contraindication for fibrinolytic therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    In Situ thrombolysis
    Intervention Description
    Group (C) will include the patients who will be treated with bed side administration of low dose of local thrombolytic therapy (In Situ) via a trans-Jugular Swan-Ganz pulmonary artery catheter. with guidance of the pressure waveforms obtained from SGC (Swan-Ganz catheter) and echocardiography guidance for ideal Catheter placement. This group will include the patients with relative contraindications for systemic thrombolysis, contraindications for contrasted administration (patients with renal impairment) and also patients with contraindications for radiation exposure (pregnant women).
    Primary Outcome Measure Information:
    Title
    Rate of mortality (mortality rate)
    Description
    number of deaths from total number of patients in each arm
    Time Frame
    30-day
    Title
    Rate of complications
    Description
    as major and minor bleedings
    Time Frame
    7 days
    Title
    Rate of Success
    Description
    number of cases with clinical success which defined as stabilization of hemodynamic parameters, resolution of hypoxia, survival from PE(pulmonary embolism) and restoring of right ventricular function (improvement of ghit ventricle and pulmonary artery pressure and decrease troponin level)
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Percent of Changes in mean blood pressure
    Description
    the percent of change in mean arterial blood pressure
    Time Frame
    Baseline (measured at first admission) and compared with measurements the following second, eighth, and 24th hours of the intervention.
    Title
    Mean pulmonary artery pressure
    Description
    Mean pulmonary artery pressure will be estimated by transthoracic echocardiography
    Time Frame
    Baseline (at addmission) and 24 hours after catheter-directed intervention
    Title
    Duration of ICU(intensive care unit) stay
    Description
    the duration of ICU (intensive care unit) stay by days
    Time Frame
    "through study completion, an average of 1 year".
    Title
    Duration of hospital stay
    Description
    the duration of hospital stay by days
    Time Frame
    "through study completion, an average of 1 year".

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age >18 years old. Both gender males and females. Patients with angiographically confirmed acute high risk pulmonary embolism with shock index >1. pulmonary arterial occlusion with >50% involvement of the central (main and/or lobar) pulmonary, and dysfunction of the right ventricle and elevated troponin. patients with high risk pulmonary embolism who remain unstable after receiving fibrinolysis patients with high risk PE pulmonary embolism who cannot receive fibrinolysis patients with intermediate high risk PE pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV (right ventricle) dysfunction, or major myocardial necrosis) Exclusion Criteria: patients with echocardiographically confirmed right sided thrombi. patients with low-risk PE pulmonary embolism or submassive acute PE pulmonary embolism with minor RV (right ventricle) dysfunction, minor myocardial necrosis, and no clinical worsening Anaphylactic reaction to contrast media. Acute renal failure or severe chronic non-dialysis dependent kidney disease. Uncooperative patient
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aliaa Ahmed, MD
    Phone
    201009087704
    Email
    aliaasalama49@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arafa abo el Hassan, lecturer
    Phone
    201017445151
    Email
    arafaelkady@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    mohamed M abd el hadi, prof
    Organizational Affiliation
    professor of chest diseases and tuberculosis
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ayman k hassan, lecturer
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    olfat M El shinnawy, prof
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Aliaa S Ahmed, MD
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17938798
    Citation
    Cohen AT, Agnelli G, Anderson FA, Arcelus JI, Bergqvist D, Brecht JG, Greer IA, Heit JA, Hutchinson JL, Kakkar AK, Mottier D, Oger E, Samama MM, Spannagl M; VTE Impact Assessment Group in Europe (VITAE). Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007 Oct;98(4):756-64.
    Results Reference
    background
    PubMed Identifier
    10227218
    Citation
    Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr 24;353(9162):1386-9. doi: 10.1016/s0140-6736(98)07534-5.
    Results Reference
    background
    PubMed Identifier
    21885244
    Citation
    Nassiri N, Jain A, McPhee D, Mina B, Rosen RJ, Giangola G, Carroccio A, Green RM. Massive and submassive pulmonary embolism: experience with an algorithm for catheter-directed mechanical thrombectomy. Ann Vasc Surg. 2012 Jan;26(1):18-24. doi: 10.1016/j.avsg.2011.05.026. Epub 2011 Aug 31.
    Results Reference
    background
    PubMed Identifier
    17626254
    Citation
    Anderson FA Jr, Zayaruzny M, Heit JA, Fidan D, Cohen AT. Estimated annual numbers of US acute-care hospital patients at risk for venous thromboembolism. Am J Hematol. 2007 Sep;82(9):777-82. doi: 10.1002/ajh.20983.
    Results Reference
    background
    PubMed Identifier
    25173341
    Citation
    Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available. Erratum In: Eur Heart J. 2015 Oct 14;36(39):2666. Eur Heart J. 2015 Oct 14;36(39):2642.
    Results Reference
    background

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    Catheter-Directed Pulmonary Reperfusion in Treatment of Pulmonary Embolism Patients

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