Status:
COMPLETED
A Study to Evaluate the Safety of Withholding Anticoagulation in Patients With Subsegmental PE Who Have a Negative Serial Bilateral Lower Extremity Ultrasound
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
University Hospital, Brest
Conditions:
Subsegmental (Single or Multiple) Pulmonary Embolism
Eligibility:
All Genders
18+ years
Brief Summary
Blood clots in lung arteries (pulmonary embolism) are usually detected using a radiological test called computed tomography (CT scan). As technology advances, the CT scans are able to detect smaller a...
Eligibility Criteria
Inclusion
- Age greater or equal to 18 years old.
- Patients with newly diagnosed isolated SSPE\* (any number).
- Isolated SSPE is defined as CTPA demonstrating an intraluminal filling defect in a subsegmental artery with no filling defects visualized at more proximal pulmonary artery levels.
Exclusion
- Proximal lower extremity (popliteal vein or above) or upper extremity (subclavian vein or above) DVT.
- Need for long term oral anticoagulant therapy for reasons other than VTE.
- SSPE diagnosed in a hospitalized patient (\> 48 hours after hospital admission).
- Requiring oxygen therapy to maintain an O2 saturation over 92%
- Previous history of DVT (proximal or distal) of upper or lower extremities, PE, or unusual site thrombosis (e.g. splanchnic or cerebral vein thrombosis).
- Geographically inaccessible for follow-up
- Active Malignancy (defined as other than basal-cell or squamous cell carcinoma of the skin; cancer within the past 6 months; any treatment for cancer in the past 6 months; or recurrent or metastatic cancer)
- Pregnancy
- Have received more than 48 hours of therapeutic anticoagulation.
- Prophylactic dose allowed if required for separate indication and acceptable by the investigator.
- Unable/refuse to sign informed consent
- Asymptomatic SSPE (e.g. SSPE is an incidental finding on a CT scan conducted for reasons other than suspected PE)
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT01455818
Start Date
March 1 2011
End Date
May 1 2021
Last Update
May 28 2021
Active Locations (9)
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1
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7
2
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
3
London Health Sciences Centre
London, Ontario, Canada
4
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6