Catheter-directed Venous Thrombolysis (CaVenT) in Acute Iliofemoral Vein Thrombosis - an open Randomized, Controlled, Clinical Trial - CaVenT
- Conditions
- Acute ilio-femoral vein thrombosis
- Registration Number
- EUCTR2005-004486-42-NO
- Lead Sponsor
- Eastern Norway Regional Health Authority
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
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
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.
11 Disease with life expectancy < 24 months.
12 Drug abuse or mental disease that may interfere with treatment and follow-up.
13 Former ipsilateral proximal DVT.
14 Chemotherapy/advanced malignant disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method