Status:
COMPLETED
Prognostic Value of Computed Tomography (CT) Scan in Hemodynamically Stable Patients With Acute Symptomatic Pulmonary Embolism
Lead Sponsor:
Carlos III Health Institute
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Brief Summary
The objectives of the PROTECT study are: * To assess the role of CT pulmonary angiography in the risk stratification of hemodynamically stable patients with acute symptomatic pulmonary embolism (PE)....
Eligibility Criteria
Inclusion
- Acute symptomatic Pulmonary Embolism (PE) confirmed by:
- CT pulmonary angiography positive for PE
- Ventilation/ perfusion lung scan with high likelihood of PE (according to PIOPED criteria)
- V/Q ventilation/ perfusion lung scan inconclusive for PE or negative CT pulmonary angiography in a patient with thoracic symptoms and a lower limb ultrasound showing a positive diagnosis for deep vein thrombosis.
Exclusion
- Contraindication for CT pulmonary angiography (allergy to iodine contrasts or creatinin clearance \< 30 ml/min).
- Informed consent not obtained.
- Pregnancy.
- Life expectancy of less than 3 months.
- Hemodynamic unstability defined as SBP \< 90 mm Hg, need for cardiopulmonary reanimation, need for vasoactive drugs or orotracheal intubation.
- Thrombectomy, insertion of filter in the cava vein, or need for fibrinolytic treatment for PE episode.
- Participation in another clinical trial for treatment of PE.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
850 Patients enrolled
Trial Details
Trial ID
NCT00880737
Start Date
February 1 2009
Last Update
June 15 2011
Active Locations (1)
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1
Ramón y Cajal Hospital
Madrid, Spain, 28034