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

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.

Study Overview

• Status: Completed
• Conditions: Thrombolytic Therapy; Pulmonary Embolism Subacute Massive
• Intervention / Treatment: Drug: Unfractionated Heparin IV; Drug: Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activator

Detailed Description

InvestIgators aimed to determine the effect of thrombolysis in Intermediate high risk pulmonary embolism patients with low bleeding risk as regards mortality and bleeding events.

Study design : randomized clinical study conducted Ain Shams University Hospitals over 2 years duration , included 100 participants divided into two groups; control group (50) and study group (50).

Participants assigned to the control group received standard treatment in the form of anticoagulation (intravenous unfractionated heparin) whole participant assigned to control group received thrombolytic therapy (streptokinase or recombinant tissue plasminogen activator) Investigators performed baseline echocardiography for all participants before receiving treatment and assessment of bleeding risk using HASBLED score Follow up of participants' vital data was done in a monitored care unit Participants were assessed one month later for dyspnea and its grade and follow up echocardiography was done also.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbassia
    • Cairo, Abbassia, Egypt, 00202
      • Ain Shams University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Non-compressible puncture sites
• Traumatic resuscitation
• Severe hypertension (systolic BP >180 mmHg)
• Advanced liver disease
• Infective endocarditis
• Active Peptic ulcer
• Patients who develop hypotension or bradycardia or allergic reaction requiring discontinuation of Streptokinase infusion.
• Patients with HAS-BLED score greater than or equals 3 (high bleeding risk for thrombolysis)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; This arm will receive standard anticoagulation in the form of intravenous unfractionated heparin	Drug: Unfractionated Heparin IV; Standard anticoagulation
Active Comparator: Study group; 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; Thrombolytic therapy acting on thrombus in pulmonary embolism patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: September 26, 2025
• First Submitted That Met QC Criteria: January 24, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 24, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Drug Therapy; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Blood Proteins; Endopeptidases; Peptide Hydrolases; Serine Endopeptidases; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Tissue Plasminogen Activator; Thrombolytic Therapy
• Other Study ID Numbers: MD129/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No