Effect of Thrombolysis on 30-day Mortality in Intermediate High Risk Pulmonary Patients With Low Bleeding Risk

NCT07374978 | Completed DMC

• 1 other identifier: MD129/2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of investigators was to study the effect and safety of Thrombolysis in Intermediate high risk pulmonary embolism patients with low bleeding risk as regards Mortality and bleeding events.

Conditions

Pulmonary Embolism Subacute Massive; Thrombolytic Therapy

Outcome Measures

Primary Outcomes (1)

• 30 day mortality and bleeding events

  Cardiac arrest due to pulmonary embolism (mortality) and major bleeding

  30 days for mortality and bleeding within hospital stay duration

Study Arms (2)

Control group

ACTIVE COMPARATOR

This arm will receive standard anticoagulation in the form of intravenous unfractionated heparin

Drug: Unfractionated Heparin IV

Study group

ACTIVE COMPARATOR

This arm will receive thrombolytic therapy in the form of either streptokinase or recombinant tissue plasminogen activator

Drug: Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activator

Interventions

Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activator DRUG

Thrombolytic therapy acting on thrombus in pulmonary embolism patients

Study group

Unfractionated Heparin IV DRUG

Standard anticoagulation

Control group

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with intermediate high risk pulmonary embolism diagnosed according to clinical probability using revised Geneva Score and diagnosis confirmed by echocardiography and Troponin I or T level and CT pulmonary angiography

You may not qualify if:

• o High risk PE
• Intermediate low risk PE
• low risk PE
• Patients with left ventricular systolic dysfunction (ischemic or non-ischemic etiology)
• Patients with chronic lung diseases (obstructive or restrictive)
• Patients with contraindications to thrombolysis:
• History of haemorrhagic stroke or stroke of unknown origin
• Ischaemic stroke in previous 6 months
• Central nervous system neoplasm
• Major trauma, surgery, or head injury in previous 3 weeks
• Bleeding diathesis (known inherited bleeding disorder, for example, haemophilia, platelet count \<50,000/uL)
• Active bleeding
• Transient ischaemic attack in previous 6 months
• Oral anticoagulation
• Pregnancy or first post-partum week

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 00202, Egypt

Location

MeSH Terms

Interventions

Thrombolytic Therapy; Tissue Plasminogen Activator

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: January 29, 2026
• Study Start: July 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 29, 2026

Record last verified: 2025-09

Locations

EG (1)