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

Ain Shams University

Status: Completed

Conditions: Thrombolytic Therapy; Pulmonary Embolism Subacute Massive

Treatments: Drug: Unfractionated Heparin IV; Drug: Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activator

Study type: Interventional

Funder types: Other

Identifiers

NCT07374978

MD129/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Unfractionated Heparin IV

Study group

Active Comparator group

Description:

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

Treatment:

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