EUCTR2005-004486-42-NO
Active, not recruiting
Not Applicable
Catheter-directed Venous Thrombolysis (CaVenT) in Acute Iliofemoral Vein Thrombosis - an open Randomized, Controlled, Clinical Trial - CaVenT
Eastern Norway Regional Health Authority0 sites200 target enrollmentNovember 4, 2005
ConditionsAcute ilio-femoral vein thrombosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute ilio-femoral vein thrombosis
- Sponsor
- Eastern Norway Regional Health Authority
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Age 18\-75 years.
- •2 Onset of symptoms \<21 days.
- •3 Objectively (ultrasonography, venography, computer tomography, or magnetic resonance imaging) verified DVT of the femoral or common iliac veins or the combined iliofemoral segment.
- •4 Informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1 Anticoagulant therapy prior to trial entry for \>7 days.
- •2 Contraindications to thrombolytic therapy, including bleeding diathesis.
- •3 Indications for thrombolytic therapy, e.g., phlegmacia coerolia dolens or vena cava thrombosis.
- •4 Severe anemia (hemoglobin \<8 g/dL).
- •5 Thrombocytopenia (platelets \<80•109/L).
- •6 Severe renal failure – creatinine clearance \<30 ml/min.
- •7 Severe hypertension, i.e. persistent systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg.
- •8 Pregnancy (but post\-partum thrombosis may be included).
- •9 Less than 14 days post\-surgery or post\-trauma.
- •10 History of subarachnoidal or intracerebral bleeding.
Outcomes
Primary Outcomes
Not specified
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