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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Pulmonary Embolism
• Intervention / Treatment: Drug: Streptokinase Injection; Device: Penumbra System

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: mariam J william; Phone Number: 01009083119; Email: mariamjoseph1997@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Hospital University
    • Contact: Mohamed O Abdelhameed, master; Phone Number: 01061878040; Email: mosman87@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients will be subjected to:

On admission:

Detailed history for assessment of risk factors

Clinical examination:

Laboratory investigations.

Trans-thoracic echocardiography to detect signs of PE:

MSCT pulmonary angiography: for assessment of site, size and shape of pulmonary embolism.

PESI and sPESI scores will be calculated for all patients.

In hospital follow up:

During hospital stay all patients will be followed up daily for assessment of hemodynamic, oxygen saturation, TTE, troponin level, need of mechanical ventilation or death.

One month follow up after discharge: for the assessment of:

Hemodynamic. Transthoracic echocardiography. MSCT pulmonary angiography.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients who received systemic thrombolysis; patients have been diagnosed with acute intermediate-high pulmonary embolism received I.V. streptokinase if there are no contraindications.	Drug: 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; Other Names: Streptase; Kabikinase
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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure		during hospital stay (about 1 week) and one month after discharge
Change in heart rate		during hospital stay (about 1 week) and one month after discharge
Change in respiratory rate		during hospital stay (about 1 week) and one month after discharge
Change of O2 saturation.		during hospital stay (about 1 week)
Change of RV signs of PE by Transthoracic echocardiography		during hospital stay (about 1 week) and one month after discharge
Need for mechanical ventilation.		during hospital stay (about 1 week)
Need for surgical intervention.	surgical embolectomy	during hospital stay (about 1 week)
Duration of hospital stay.		during hospital stay (about 1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of Perforation of pulmonary artery	may occur during catheter directed interventions	during hospital stay (about 1 week)
incidence of pericardial effusion	due to: infection cardiac perforation during catheter directed interventions	during hospital stay (about 1 week) and one month after discharge
incidence of Major bleeding	that requires blood transfusions or urgent intervention	during hospital stay (about 1 week) and one month after discharge

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Ayman K Mohamed, PHD, Assiut University; Study Director: Mohamed O Abdelhameed, master, Assiut University

Publications and helpful links

Helpful Links

• ESC guidelines

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: acute pulmonary embolism; intermediate-high; systemic thrombolysis; catheter- directed management
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Streptokinase
• Other Study ID Numbers: 123456@qerty

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes