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

NCT ID: NCT06545864

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2030-03-01

Brief Summary

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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).

Detailed Description

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Conditions

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Acute Pulmonary Embolism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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patients who received systemic thrombolysis

patients have been diagnosed with acute intermediate-high pulmonary embolism received I.V. streptokinase if there are no contraindications.

Streptokinase Injection

Intervention Type 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

patients who underwent catheter-based intervention

patients have been diagnosed with acute intermediate-high pulmonary embolism underwent catheter-based intervention including thrombus aspiration or catheter directed thrombolysis using Penumbra System

Penumbra System

Intervention Type 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

Interventions

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Streptokinase Injection

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

Intervention Type DRUG

Penumbra System

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

Intervention Type DEVICE

Other Intervention Names

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Kabikinase Streptase

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mariam J William

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayman K Mohamed, PHD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Mohamed O Abdelhameed, master

Role: STUDY_DIRECTOR

Assiut University

Locations

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Hospital University

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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mariam J william

Role: CONTACT

01009083119

Facility Contacts

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Mohamed O Abdelhameed, master

Role: primary

01061878040

Other Identifiers

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123456@qerty

Identifier Type: -

Identifier Source: org_study_id

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