Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare in hospital clinical outcomes and one month follow up of systemic thrombolysis versus catheter directed management for the treatment of acute intermediate- high risk pulmonary embolism (using streptokinase or tissue plasminogen activator (TPA) and catheter-based intervention group using Penumbra System).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients who received systemic thrombolysis | patients have been diagnosed with acute intermediate-high pulmonary embolism received I.V. streptokinase if there are no contraindications. |
| |
| patients who underwent catheter-based intervention | patients have been diagnosed with acute intermediate-high pulmonary embolism underwent catheter-based intervention including thrombus aspiration or catheter directed thrombolysis using Penumbra System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Streptokinase Injection | Drug | 250000 IU as a loading dose over 30 min. Followed by 100000 IU/hour over 12:24hours or accelerated regimen 1.5 million IU over 2 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | during hospital stay (about 1 week) and one month after discharge | |
| Change in heart rate | during hospital stay (about 1 week) and one month after discharge | |
| Change in respiratory rate | during hospital stay (about 1 week) and one month after discharge | |
| Change of O2 saturation. | during hospital stay (about 1 week) | |
| Change of RV signs of PE by Transthoracic echocardiography | during hospital stay (about 1 week) and one month after discharge | |
| Need for mechanical ventilation. | during hospital stay (about 1 week) | |
| Need for surgical intervention. | surgical embolectomy | during hospital stay (about 1 week) |
| Duration of hospital stay. | during hospital stay (about 1 week) |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of Perforation of pulmonary artery | may occur during catheter directed interventions | during hospital stay (about 1 week) |
| incidence of pericardial effusion | due to: infection cardiac perforation during catheter directed interventions |
Not provided
Inclusion Criteria:
Patients diagnosed with acute intermediate-high pulmonary embolism
Exclusion Criteria:
Not provided
Not provided
Not provided
All patients will be subjected to:
On admission:
Detailed history for assessment of risk factors
Clinical examination:
Laboratory investigations.
Trans-thoracic echocardiography to detect signs of PE:
MSCT pulmonary angiography: for assessment of site, size and shape of pulmonary embolism.
PESI and sPESI scores will be calculated for all patients.
In hospital follow up:
During hospital stay all patients will be followed up daily for assessment of hemodynamic, oxygen saturation, TTE, troponin level, need of mechanical ventilation or death.
One month follow up after discharge: for the assessment of:
Hemodynamic. Transthoracic echocardiography. MSCT pulmonary angiography.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mariam J william | Contact | 01009083119 | mariamjoseph1997@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ayman K Mohamed, PHD | Assiut University | Principal Investigator |
| Mohamed O Abdelhameed, master | Assiut University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital University | Asyut | Egypt |
|
compare in hospital clinical outcomes and one month follow up of systemic thrombolysis versus catheter directed management for the treatment of acute intermediate- high risk pulmonary embolism (using streptokinase or tissue plasminogen activator (TPA) and catheter-based intervention group using Penumbra System).
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013300 | Streptokinase |
| ID | Term |
|---|---|
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Penumbra System | Device | which comprised of several devices:
|
|
| during hospital stay (about 1 week) and one month after discharge |
| incidence of Major bleeding | that requires blood transfusions or urgent intervention | during hospital stay (about 1 week) and one month after discharge |
| D045762 |
| Enzymes and Coenzymes |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |