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

NCT06545864 | Not Yet Recruiting DMC FDA Drug FDA Device

• 1 other identifier: 123456@qerty
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Pulmonary Embolism

Keywords

intermediate-high; acute pulmonary embolism; systemic thrombolysis; catheter- directed management

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• incidence of Perforation of pulmonary artery

  during hospital stay (about 1 week)

• incidence of pericardial effusion

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

• incidence of Major bleeding

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

Study Arms (2)

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

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

Interventions

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

Also known as: Kabikinase, Streptase

patients who received systemic thrombolysis

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

patients who underwent catheter-based intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients diagnosed with acute intermediate-high pulmonary embolism

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Hospital University

Asyut, Egypt

Location

MeSH Terms

Interventions

Streptokinase

Intervention Hierarchy (Ancestors)

Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Ayman K Mohamed, PHD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Mohamed O Abdelhameed, master

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

mariam J william

CONTACT

01009083119; mariamjoseph1997@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 9, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

EG (1)