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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 10, 2005
Last Update Posted: April 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Hospital Ostfold, Fredrikstad
Information provided by (Responsible Party):
Oslo University Hospital
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 venous thrombolysis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Catheter-directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis, an Open Randomized, Controlled, Clinical Trial

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Patency after 6 months [ Time Frame: 6 months ]
  • Post-thrombotic syndrome after 2 years (yrs) [ Time Frame: 2 years ]

Secondary Outcome 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 ]

Enrollment: 209
Study Start Date: January 2006
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I 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.
No Intervention: II


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251771

Ullevaal University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
Hospital Ostfold, Fredrikstad
Study Director: Per Morten Sandset, MD Ullevaal University Hospital
  More Information

Additional Information:
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. doi: 10.1111/j.1538-7836.2009.03464.x. 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.
Enden T, Kløw NE, Sandset PM. [Catheter-directed thrombolysis in acute deep venous thrombosis]. Tidsskr Nor Laegeforen. 2006 Jun 22;126(13):1765. Norwegian.
Enden T, Sandvik L, Kløw 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. 2009 Jun;23(2):369-74. doi: 10.1111/j.1471-6712.2008.00618.x. Epub 2008 Nov 12.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00251771     History of Changes
Other Study ID Numbers: 1.2005.650
EUDRACT No.2005-004486-42
First Submitted: November 9, 2005
First Posted: November 10, 2005
Last Update Posted: April 30, 2015
Last Verified: November 2014

Keywords provided by Oslo University Hospital:
Thrombolytic therapy
Postphlebitic syndrome
Venous thrombosis

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

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