SSPE * The Management of Subsegmental Pulmonary Embolism: A Prospective Cohort Study
- Conditions
- Pulmonary embolismvenous thromboembolism10014523
- Registration Number
- NL-OMON43375
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
1) 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.
2) Signed and dated informed consent of the subject available before the start of any specific study procedures;
3) Age *18 years.
1) Concomitant Proximal lower extremity (popliteal vein or above) or upper extremity (subclavian vein or above) DVT.
2) Need for long term oral anticoagulant therapy for reasons other than VTE.
3) SSPE diagnosed in a hospitalized patient (> 48 hours after hospital admission).
4) Requiring oxygen therapy to maintain an O2 saturation over 92%
5) Previous history of DVT (proximal or distal) of upper or lower extremities, PE, or unusual site thrombosis (e.g. splanchnic or cerebral vein thrombosis).
6) 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)
7) Pregnancy
8) Have received more than 48 hours of therapeutic anticoagulation. Prophylactic dose allowed if required for separate indication AND acceptable by the investigator.
9) Unable/refuse to sign informed consent or Geographically inaccessible for follow-up
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>See chapter 'endpoints' of study protocol (page 14-16)</p><br>
- Secondary Outcome Measures
Name Time Method <p>See chapter 'endpoints' of study protocol (page 14-16)</p><br>