Effect of Thrombolysis on 30-day Mortality in Intermediate High Risk Pulmonary Patients With Low Bleeding Risk
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 30 day mortality and bleeding events
Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control group
This arm will receive standard anticoagulation in the form of intravenous unfractionated heparin
Intervention: Unfractionated Heparin IV (Drug)
Study group
This arm will receive thrombolytic therapy in the form of either streptokinase or recombinant tissue plasminogen activator
Intervention: Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activator (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported