See chapter 'objectives' of study protocol (page 12)
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
See chapter 'endpoints' of study protocol (page 14-16)
Secondary outcome
See chapter 'endpoints' of study protocol (page 14-16)
Background summary
See chapter 'introduction' of study protocol (page 8-12)
Study objective
See chapter 'objectives' of study protocol (page 12)
Study design
See chapter 'design' of study protocol (page 12)
Intervention
See chapter 'intervention' of study protocol (page 14)
Study burden and risks
See chapter ' Benefits and risk assessment, group relatedness' of study
protocol (page 24)
Ottawa Hospital General Campus,
Leiden 501 Smyth RD, Room L2271, Ottawa, Ontario, Canada
NL
Ottawa Hospital General Campus,
Leiden 501 Smyth RD, Room L2271, Ottawa, Ontario, Canada
NL
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT01455818 |
CCMO | NL56148.058.16 |