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Catheter Directed Interventions in Pulmonary Embolism

Primary Purpose

Pulmonary Embolism

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
catheter directed fragmentation and thrombolysis
Streptokinase
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism

Eligibility Criteria

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

Inclusion Criteria:

  • 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 pulmonary hypertension (mean pulmonary artery pressure >25 mmHg)
  • Patients with high risk pulmonary embolism who remain unstable after receiving fibrinolysis
  • Patients with high risk pulmonary embolism who cannot receive fibrinolysis
  • Patients with acute intermediate-high risk pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV dysfunction, or major myocardial necrosis)

Exclusion Criteria:

  • Patients with echocardiographically confirmed right sided thrombi.
  • Patients with low-risk pulmonary embolism or intermediater-low risk acute pulmonary embolism with minor RV dysfunction, minor myocardial necrosis, and no clinical worsening
  • Acute gastrointestinal bleeding.
  • Anticoagulation with international normalized ratio >1.8 or severe coagulopathy.
  • Anaphylactic reaction to contrast media.
  • Acute stroke.
  • Acute renal failure or severe chronic non-dialysis dependent kidney disease.
  • Uncooperative patient

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    catheter directed interventions

    systemic thrombolysis

    Arm Description

    Those patients will undergo catheter directed fragmentation followed by local thrombolysis using streptokinase

    Those patients will receive systemic streptokinase

    Outcomes

    Primary Outcome Measures

    30-day mortality
    measure the estimates of deaths in the 30 days after pulmonary embolism diagnosis

    Secondary Outcome Measures

    Changes in blood pressure
    systolic and diastolic blood pressure will be measured at first admission and compared with measurements the following second, eighth, and 24th hours of the intervention
    oxygen saturation
    oxygen saturation will be measured by arterial blood gases analysis at first admission and compared with measurements the following second, eighth, and 24th hours of the intervention
    changes in right ventricular dysfunction
    right ventricular dysfunction will be assessed by echocardiography and Mean pulmonary artery systolic pressure will be estimated by transthoracic echocardiography at first admission and 24 hours after catheter-directed intervention

    Full Information

    First Posted
    July 12, 2018
    Last Updated
    July 21, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03595085
    Brief Title
    Catheter Directed Interventions in Pulmonary Embolism
    Official Title
    Safety and Efficacy of Catheter Directed Interventions in Acute High Risk Pulmonary Embolism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2018 (Anticipated)
    Primary Completion Date
    October 1, 2020 (Anticipated)
    Study Completion Date
    March 1, 2021 (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

    5. Study Description

    Brief Summary
    Evaluating the safety and outcomes of catheter directed thrombolysis following catheter fragmentation in acute high risk pulmonary embolism
    Detailed Description
    Acute pulmonary embolism is common, but its presentation highly varies ranging from asymptomatic to massive pulmonary embolism. Massive pulmonary embolism is a common life-threatening condition and represents the most serious manifestation among venous thromboembolic disease. Acute pulmonary embolism is considered the third most common cause of death among hospitalized patients . The mortality rate can exceed 58% in patients with acute pulmonary embolism presenting with haemodynamic instability , mostly occur within 1 hour of presentation. In patients with high risk pulmonary embolism , the main aim of therapy is to rapidly recanalize the affected pulmonary arteries with thrombolysis or embolectomy; to decrease right ventricular afterload and reverse right ventricular failure and shock, prevent chronic thromboembolic pulmonary hypertension , and decrease the recurrence risk. The first-line treatment in patients with acute high risk pulmonary embolism presenting with persistent hypotension and/or cardiogenic shock is intravenous thrombolytic therapy. However a significant proportion of patients may not be a candidate for Intravenous thrombolysis because of major contraindications. An alternative option in patients with absolute contraindications or has failed intravenous thrombolysis is surgical embolectomy , but the number of experienced tertiary care centers that can do emergency surgical embolectomy are limited. Percutaneous catheter mechanical fragmentation of proximal pulmonary arterial clots followed by local thrombolytic therapy is accepted as an alternative to intravenous thrombolytic therapy and surgical embolectomy because of their ability to rapidly recanalize occluded pulmonary blood flow. Several reports have shown that catheter-directed therapy is a safe and effective treatment for acute PE to restore pulmonary flow and decreasing Pulmonary artery systolic pressure , However, current knowledge on efficacy and safety of catheter-directed therapy in management of intermediate high risk pulmonary embolism is limited.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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
    catheter directed interventions
    Arm Type
    Experimental
    Arm Description
    Those patients will undergo catheter directed fragmentation followed by local thrombolysis using streptokinase
    Arm Title
    systemic thrombolysis
    Arm Type
    Active Comparator
    Arm Description
    Those patients will receive systemic streptokinase
    Intervention Type
    Procedure
    Intervention Name(s)
    catheter directed fragmentation and thrombolysis
    Intervention Description
    A(6)F multipurpose catheter will be advanced over a guide wire under fluoroscopic guidance and used to measure right heart and pulmonary artery pressures, then mechanical catheter fragmentation will be done using a pigtail catheter. The catheter will be quickly spun manually so as to fragment the central thrombus and establish initial flow into pulmonary artery. After ensuring initial flow, Initial bolus dose of streptokinase (250.000 international unit) will be given over 10 min followed by continuous infusion of (100.000 international unit per hour)for 24 hours
    Intervention Type
    Drug
    Intervention Name(s)
    Streptokinase
    Intervention Description
    intravenous streptokinase at a dose of 250 000 international unit as a loading dose over 30 minutes, followed by 100 000 international unit per hour over 12-24 hours
    Primary Outcome Measure Information:
    Title
    30-day mortality
    Description
    measure the estimates of deaths in the 30 days after pulmonary embolism diagnosis
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Changes in blood pressure
    Description
    systolic and diastolic blood pressure will be measured at first admission and compared with measurements the following second, eighth, and 24th hours of the intervention
    Time Frame
    24 hours
    Title
    oxygen saturation
    Description
    oxygen saturation will be measured by arterial blood gases analysis at first admission and compared with measurements the following second, eighth, and 24th hours of the intervention
    Time Frame
    24 hours
    Title
    changes in right ventricular dysfunction
    Description
    right ventricular dysfunction will be assessed by echocardiography and Mean pulmonary artery systolic pressure will be estimated by transthoracic echocardiography at first admission and 24 hours after catheter-directed intervention
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 pulmonary hypertension (mean pulmonary artery pressure >25 mmHg) Patients with high risk pulmonary embolism who remain unstable after receiving fibrinolysis Patients with high risk pulmonary embolism who cannot receive fibrinolysis Patients with acute intermediate-high risk pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV dysfunction, or major myocardial necrosis) Exclusion Criteria: Patients with echocardiographically confirmed right sided thrombi. Patients with low-risk pulmonary embolism or intermediater-low risk acute pulmonary embolism with minor RV dysfunction, minor myocardial necrosis, and no clinical worsening Acute gastrointestinal bleeding. Anticoagulation with international normalized ratio >1.8 or severe coagulopathy. Anaphylactic reaction to contrast media. Acute stroke. Acute renal failure or severe chronic non-dialysis dependent kidney disease. Uncooperative patient

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18296591
    Citation
    Heit JA. The epidemiology of venous thromboembolism in the community. Arterioscler Thromb Vasc Biol. 2008 Mar;28(3):370-2. doi: 10.1161/ATVBAHA.108.162545. No abstract available.
    Results Reference
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    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
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    PubMed Identifier
    11265879
    Citation
    Uflacker R. Interventional therapy for pulmonary embolism. J Vasc Interv Radiol. 2001 Feb;12(2):147-64. doi: 10.1016/s1051-0443(07)61821-1.
    Results Reference
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    PubMed Identifier
    9350909
    Citation
    Kasper W, Konstantinides S, Geibel A, Olschewski M, Heinrich F, Grosser KD, Rauber K, Iversen S, Redecker M, Kienast J. Management strategies and determinants of outcome in acute major pulmonary embolism: results of a multicenter registry. J Am Coll Cardiol. 1997 Nov 1;30(5):1165-71. doi: 10.1016/s0735-1097(97)00319-7.
    Results Reference
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    PubMed Identifier
    17261411
    Citation
    Stein PD, Alnas M, Beemath A, Patel NR. Outcome of pulmonary embolectomy. Am J Cardiol. 2007 Feb 1;99(3):421-3. doi: 10.1016/j.amjcard.2006.08.050. Epub 2006 Dec 15.
    Results Reference
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    PubMed Identifier
    29843174
    Citation
    Engelberger RP, Kucher N. Reperfusion Treatment for Acute Pulmonary Embolism. Hamostaseologie. 2018 May;38(2):98-105. doi: 10.1055/s-0038-1641717. Epub 2018 May 29.
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    PubMed Identifier
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    Citation
    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.
    Results Reference
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    PubMed Identifier
    23710301
    Citation
    Mohan B, Chhabra ST, Aslam N, Wander GS, Sood NK, Verma S, Mehra AK, Sharma S. Mechanical breakdown and thrombolysis in subacute massive pulmonary embolism: A prospective trial. World J Cardiol. 2013 May 26;5(5):141-7. doi: 10.4330/wjc.v5.i5.141.
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    Citation
    Dilektasli AG, Demirdogen Cetinoglu E, Acet NA, Erdogan C, Ursavas A, Ozkaya G, Coskun F, Karadag M, Ege E. Catheter-Directed Therapy in Acute Pulmonary Embolism with Right Ventricular Dysfunction: A Promising Modality to Provide Early Hemodynamic Recovery. Med Sci Monit. 2016 Apr 15;22:1265-73. doi: 10.12659/msm.897617.
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    Catheter Directed Interventions in Pulmonary Embolism

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