Status:
COMPLETED
Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Venous Thromboembolism
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Blood clots in leg veins (deep vein thrombosis) or lung arteries (pulmonary embolism) that happen for no reason (i.e. unexplained) are both called "unprovoked venous thromboembolism" (VTE). These unex...
Eligibility Criteria
Inclusion
- Patients with a new diagnosis of unprovoked proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) will be eligible to participate into the study:
- Unprovoked VTE is defined as the absence of any of the following predisposing factors:
- known active cancer;
- recent (less than 3 months) paralysis, paresis or plaster immobilization of the lower extremities;
- recently bedridden for period of 3 or more days, or major surgery, within the previous 12 weeks requiring general or regional anaesthesia;
- previous unprovoked VTE;
- known thrombophilia (hereditary or acquired)
- Proximal DVT is defined as a non-compressibility of any vein segment from the common femoral vein to the trifurcation of the popliteal vein or a persistent intra-luminal filling defect of the iliac, common femoral, superficial femoral or popliteal veins on contrast venography.
- Pulmonary embolism is defined as:
- patients with a high/intermediate pre-test probability (Wells' model \> 4) + high probability V/Q scan;
- positive pulmonary angiogram; or
- spiral CT demonstrating intraluminal filling defect in a vessel larger than a segmental artery
Exclusion
- Patients will be excluded from the study if they have any of the following criteria:
- Age \< 18 years-old;
- Refusal or inability to provide informed consent;
- Greater than 21 days post diagnosis of idiopathic VTE
- Index VTE event of UEDVT or unusual site DVT
- Diagnosis of SSPE in the absence of above or below knee DVT
- Allergy to contrast media;
- Creatinine clearance \< 60 ml/min;
- Claustrophobia or agoraphobia;
- Weight \> 130 kg;
- Diagnosis of ulcerative colitis; and
- Diagnosis of glaucoma
- Current pregnancy
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
862 Patients enrolled
Trial Details
Trial ID
NCT00773448
Start Date
September 1 2008
End Date
April 1 2015
Last Update
July 7 2015
Active Locations (9)
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1
St. Boniface Hospital
Winnipeg, Manitoba, Canada
2
Capital Health Centre for Research
Halifax, Nova Scotia, Canada
3
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
4
London Health Sciences Center
London, Ontario, Canada