NCT04911192

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

May 25, 2021

Last Update Submit

June 14, 2021

Conditions

Pulmonary Embolism

Keywords

pulmonary embolism

Outcome Measures

Primary Outcomes (3)

  • Rate of mortality (mortality rate)

    number of deaths from total number of patients in each arm

    30-day

  • Rate of complications

    as major and minor bleedings

    7 days

  • 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)

    2 weeks

Secondary Outcomes (4)

  • Percent of Changes in mean blood pressure

    Baseline (measured at first admission) and compared with measurements the following second, eighth, and 24th hours of the intervention.

  • Mean pulmonary artery pressure

    Baseline (at addmission) and 24 hours after catheter-directed intervention

  • Duration of ICU(intensive care unit) stay

    "through study completion, an average of 1 year".

  • Duration of hospital stay

    "through study completion, an average of 1 year".

Study Arms (3)

systemic thrombolysis group

NO INTERVENTION

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

mechanical fragmentation group

ACTIVE COMPARATOR

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

Procedure: mechanical fragmentation

In Situ thrombolysis group

ACTIVE COMPARATOR

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).

Procedure: In Situ thrombolysis

Interventions

mechanical fragmentationPROCEDURE

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

mechanical fragmentation group
In Situ thrombolysisPROCEDURE

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).

In Situ thrombolysis group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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. doi: 10.1160/TH07-03-0212.

    PMID: 17938798BACKGROUND

  • 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.

    PMID: 10227218BACKGROUND

  • 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.

    PMID: 21885244BACKGROUND

  • 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.

    PMID: 17626254BACKGROUND

  • 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.

    PMID: 25173341BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • mohamed M abd el hadi, prof

    professor of chest diseases and tuberculosis

    PRINCIPAL INVESTIGATOR

  • Ayman k hassan, lecturer

    Assiut University

    STUDY DIRECTOR

  • olfat M El shinnawy, prof

    Assiut University

    STUDY CHAIR

  • Aliaa S Ahmed, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aliaa Ahmed, MD

CONTACT

201009087704aliaasalama49@gmail.com

Arafa abo el Hassan, lecturer

CONTACT

201017445151arafaelkady@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

May 25, 2021

First Posted

June 2, 2021

Study Start

June 30, 2021

Primary Completion

June 30, 2023

Study Completion

December 30, 2023

Last Updated

June 18, 2021

Record last verified: 2021-06