Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis

Brief Summary

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

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%.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: December 2014

Interventions Used in this Clinical Trial

  • Procedure: catheter-directed venous thrombolysis
    • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: I
  • No Intervention: II

Outcome Measures for this Clinical Trial

Primary Measures

  • Patency after 6 months
    • Time Frame: 6 months
  • Post-thrombotic syndrome after 2 years (yrs)
    • Time Frame: 2 years

Secondary Measures

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

Criteria for Participation in this Clinical Trial

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 <80×10^9/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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Oslo University Hospital
  • Collaborator
    • Hospital Ostfold, Fredrikstad
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Per Morten Sandset, MD, Study Director, Ullevaal University Hospital

References

Enden T, Klow NE, Sandset PM. [Catheter-directed thrombolysis in acute deep venous thrombosis] Tidsskr Nor Laegeforen. 2006 Jun 22;126(13):1765. Norwegian. No abstract available.

Enden T, Sandvik L, Klow NE, Hafsahl G, Holme PA, Holmen LO, Ghanima W, Njaastad AM, Sandbaek G, Slagsvold CE, Sandset PM. Catheter-directed Venous Thrombolysis in acute iliofemoral vein thrombosis–the CaVenT study: rationale and design of a multicenter, randomized, controlled, clinical trial (NCT00251771). Am Heart J. 2007 Nov;154(5):808-14. Epub 2007 Sep 6.

Enden T, Garratt AM, Kløw NE, Sandset PM. Assessing burden of illness following acute deep vein thrombosis: data quality, reliability and validity of the Norwegian version of VEINES-QOL/Sym, a disease-specific questionnaire. Scand J Caring Sci. 2008 Nov 12; [Epub ahead of print]

Enden T, Sandset PM, Kløw NE. Evidence-based practice for patients with severe venous thrombosis. Tidsskr Nor Laegeforen. 2012 May 29;132(10):1215-6. doi: 10.4045/tidsskr.12.0474. English, Norwegian.

Citations Reporting on Results

Enden T, Kløw NE, Sandvik L, Slagsvold CE, Ghanima W, Hafsahl G, Holme PA, Holmen LO, Njaastad AM, Sandbaek G, Sandset PM; CaVenT study group. Catheter-directed thrombolysis vs. anticoagulant therapy alone in deep vein thrombosis: results of an open randomized, controlled trial reporting on short-term patency. J Thromb Haemost. 2009 Aug;7(8):1268-75. Epub 2009 Apr 30.

Enden T, Haig Y, Kløw NE, Slagsvold CE, Sandvik L, Ghanima W, Hafsahl G, Holme PA, Holmen LO, Njaastad AM, Sandbæk G, Sandset PM; CaVenT Study Group. Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial. Lancet. 2012 Jan 7;379(9810):31-8. doi: 10.1016/S0140-6736(11)61753-4. Epub 2011 Dec 13.

Haig Y, Enden T, Slagsvold CE, Sandvik L, Sandset PM, Kløw NE. Determinants of early and long-term efficacy of catheter-directed thrombolysis in proximal deep vein thrombosis. J Vasc Interv Radiol. 2013 Jan;24(1):17-24; quiz 26. doi: 10.1016/j.jvir.2012.09.023. Epub 2012 Nov 22.

Enden T, Resch S, White C, Wik HS, Kløw NE, Sandset PM. Cost-effectiveness of additional catheter-directed thrombolysis for deep vein thrombosis. J Thromb Haemost. 2013 Jun;11(6):1032-42. doi: 10.1111/jth.12184.

Enden T, Wik HS, Kvam AK, Haig Y, Kløw NE, Sandset PM. Health-related quality of life after catheter-directed thrombolysis for deep vein thrombosis: secondary outcomes of the randomised, non-blinded, parallel-group CaVenT study. BMJ Open. 2013 Aug 29;3(8):e002984. doi: 10.1136/bmjopen-2013-002984.

Enden T, Kløw NE, Sandset PM. Symptom burden and job absenteeism after treatment with additional catheter-directed thrombolysis for deep vein thrombosis. Patient Relat Outcome Meas. 2013 Sep 16;4:55-9. doi: 10.2147/PROM.S47233. eCollection 2013.

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