Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis

Study Overview
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Brief Summary
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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%.

Official Title
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Catheter-directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis, an Open Randomized, Controlled, Clinical Trial

Conditions
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Deep Vein Thrombosis

Intervention / Treatment
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* Procedure: catheter-directed venous thrombolysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br> | Procedure: catheter-directed venous thrombolysis<br>* catheter-directed continuous intravenous infusion of alteplase 0.01mg/kg/h and low-dose heparin. Max dose 20mg/24 h and up to 96 hrs.<br>|
| No Intervention: II<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency after 6 months |  | 6 months | 
| Post-thrombotic syndrome after 2 years (yrs) |  | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombolytic therapy, Postphlebitic syndrome, Venous thrombosis