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%.

Condition	Intervention
Deep Vein Thrombosis	Procedure: Catheter-directed thrombolysis, using alteplase

Further study details as provided by Ullevaal University Hospital:

Primary Outcomes: Patency after 6 months; Post-thrombotic syndrome after 2 years (yrs)
Secondary Outcomes: Frequency of clinically relevant bleeding complications; Effects on quality of life; Cost-effectiveness of treatment; Procedural success of CDT; Markers of importance for successful thrombolysis; Patency at 2 yrs; PTS at 6, 12, 36, 48 and 60 months; Relation between PTS and patency; Prevalence of vein anomalies; Prevalence of underlying thrombophilia; Frequency of recurrent venous thrombotic events (VTE); Markers of importance for recurrent thrombosis
Expected Total Enrollment:  200

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00251771

Tone R. Enden, MD      +47 22 11 90 40    tone.enden@medisin.uio.no

Norway
      Ullevaal University Hospital, Oslo,  0407,  Norway

Study chairs or principal investigators

Per Morten Sandset, MD,  Study Director,  Ullevaal University Hospital   

Study ID Numbers:  1.2005.650
Last Updated:  December 15, 2005
Record first received:  November 9, 2005
ClinicalTrials.gov Identifier:  NCT00251771
Health Authority: Norway: Directorate for Health and Social Affairs
ClinicalTrials.gov processed this record on 2006-01-10