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NCT Number: NCT06545864

Systemic Thrombolysis Versus Catheter Directed Management for Acute Intermediate-high Pulmonary Embolism

To compare in hospital clinical outcomes and one month follow up of systemic thrombolysis versus catheter directed management for the treatment of acute intermediate- high risk pulmonary embolism (using streptokinase or tissue plasminogen activator (TPA) and catheter-based intervention group using Penumbra System).

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Key information

Conditions

Acute Pulmonary Embolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients diagnosed with acute intermediate-high pulmonary embolism

Exclusion criteria

  • Patients less than 18 years of age.
  • Low risk, intermediate low risk, acute pulmonary embolism
  • patients with RV masses will be excluded.
  • Patient refusal of treatment strategy.

Treatment and study plan

Streptokinase Injection

Drug

250000 IU as a loading dose over 30 min. Followed by 100000 IU/hour over 12:24hours or accelerated regimen 1.5 million IU over 2 hours

Other names: Kabikinase, Streptase

Penumbra System

Device

which comprised of several devices:

  • RED Reperfusion Catheters
  • Penumbra JET Reperfusion Catheters
  • ACE Reperfusion Catheters
  • MAX Reperfusion Catheters
  • 3D Revascularization Device
  • Penumbra ENGINE Aspiration Source
  • Penumbra ENGINE Canister
  • Aspiration Tubing

Primary outcomes

  1. Change in blood pressure

    Time frame: during hospital stay (about 1 week) and one month after discharge

  2. Change in heart rate

    Time frame: during hospital stay (about 1 week) and one month after discharge

  3. Change in respiratory rate

    Time frame: during hospital stay (about 1 week) and one month after discharge

  4. Change of O2 saturation.

    Time frame: during hospital stay (about 1 week)

  5. Change of RV signs of PE by Transthoracic echocardiography

    Time frame: during hospital stay (about 1 week) and one month after discharge

  6. Need for mechanical ventilation.

    Time frame: during hospital stay (about 1 week)

  7. Need for surgical intervention.

    Time frame: during hospital stay (about 1 week)

    surgical embolectomy

  8. Duration of hospital stay.

    Time frame: during hospital stay (about 1 week)

Secondary outcomes

  1. incidence of Perforation of pulmonary artery

    Time frame: during hospital stay (about 1 week)

    may occur during catheter directed interventions

  2. incidence of pericardial effusion

    Time frame: during hospital stay (about 1 week) and one month after discharge

    due to: infection cardiac perforation during catheter directed interventions

  3. incidence of Major bleeding

    Time frame: during hospital stay (about 1 week) and one month after discharge

    that requires blood transfusions or urgent intervention

Study contacts

Contact information is provided by the study sponsor or research team.

mariam J william

CONTACT

[email protected]

01009083119

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

In Hospital Clinical Outcomes and Short Term Follow up of Systemic Thrombolysis Versus Catheter Directed Management for the Treatment of Acute Intermediate-high Pulmonary Embolism

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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