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Completed

NCT Number: NCT07374978

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.

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Abbassia, 00202, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Unfractionated Heparin IV

Drug

Standard anticoagulation

Primary outcomes

  1. 30 day mortality and bleeding events

    Time frame: 30 days for mortality and bleeding within hospital stay duration

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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