Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis

Not Applicable

Completed

• Conditions: Deep Vein Thrombosis
• Interventions: Procedure: catheter-directed venous thrombolysis

• Registration Number: NCT00251771
• Lead Sponsor: Oslo University Hospital

Brief Summary

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%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-09
• Study First Submitted QC: 2005-11-09
• Study First Posted: 2005-11-10
• Study Start: 2006-01
• Status Verified: 2014-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	catheter-directed venous thrombolysis	-

Primary Outcome Measures

Name	Time	Method
Patency after 6 months	6 months
Post-thrombotic syndrome after 2 years (yrs)	2 years

Secondary Outcome Measures

Name	Time	Method
Patency at 2 years	2 years
Markers of importance for recurrent thrombosis	0.5, 2 and 5 years
Prevalence of vein anomalies	6 months
Prevalence of underlying thrombophilia	1 year
Effects on quality of life	2 and 5 years
Frequency of clinically relevant bleeding complications	1 year
Cost-effectiveness of treatment	2 years
Procedural success of CDT	1 week
PTS at 6, 12, 36, 48 and 60 months	6, 12, 36, 48 and 60 months
Relation between PTS and patency	2 years
Frequency of recurrent venous thrombotic events (VTE)	0.5, 2 and 5 years
Markers of importance for successful thrombolysis	2 years

Trial Locations

Locations (1)

Ullevaal University Hospital; 🇳🇴 Oslo, Norway