Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis (CaVenT)

University of Oslo (UIO)

Status

Completed

Conditions

Deep Vein Thrombosis

Treatments

Procedure: catheter-directed venous thrombolysis

Study type

Interventional

Funder types

Other

Identifiers

NCT00251771

EUDRACT No.2005-004486-42

1.2005.650

Details and patient eligibility

About

Deep vein thrombosis (DVT) is a severe disease, and conventional treatment with low molecular weight heparin (LMWH) and warfarin is associated with some degree of long-term sequelae, i.e. post-thrombotic syndrome (PTS). Catheter-directed thrombolytic (CDT) therapy has been introduced worldwide the last two decades. Reports have suggested a beneficial effect of this costly treatment, but there are no randomized clinical trials documenting its short- and long-term efficacy and safety. This multi-center study will randomize patients with acute iliofemoral vein thrombosis to either conventional treatment or CDT in addition to conventional treatment. Main outcome parameters are patency rates at 6 months and prevalence of PTS at 24 months. The main short-term hypothesis is that CDT of first-time acute DVT will increase patency of the affected segments after 6 months from <50% to >80%. The main long-term hypothesis is that CDT will improve long-term functional outcome, i.e. risk of PTS after 2 years from >25% to <10%.

Enrollment

209 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Onset of symptoms <21 days
Objectively verified DVT of the femoral or common iliac veins or the combined iliofemoral segment
Informed consent

Exclusion criteria

Anticoagulant therapy prior to trial entry >7 days
Contraindications to thrombolytic therapy
Indications for thrombolytic therapy, i.e. phlegmasia coerulea dolens or vena cava thrombosis
Severe anemia, hemoglobin (hgb)<8 g/dl
Thrombocytopenia, platelets <80x10^9/l
Severe renal failure, creatinine clearance <30ml/min
Severe hypertension, systolic (syst) blood pressure (BP)>160 mmHg or diastolic (diast) BP >100 mmHg pregnancy
Less than 14 days post-surgery or post-trauma
History of subarachnoidal or intracerebral bleeding
Disease with life expectancy <24 months
Drug abuse or mental disease that may interfere with treatment and follow-up
Former ipsilateral proximal DVT
Chemotherapy or advanced malignant disease