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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | This arm will receive standard anticoagulation in the form of intravenous unfractionated heparin |
|
| Study group | Active Comparator | This arm will receive thrombolytic therapy in the form of either streptokinase or recombinant tissue plasminogen activator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
o High risk PE
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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Abbassia | 00202 | Egypt |
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| Unfractionated Heparin IV | Drug | Standard anticoagulation |
|
| ID | Term |
|---|---|
| D015912 | Thrombolytic Therapy |
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
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