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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University Hospital, Aker
Oslo University Hospital
Hospital Ostfold, Fredrikstad
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00251771
First received: November 9, 2005
Last updated: April 18, 2011
Last verified: April 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 200
Study Start Date: January 2006
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: December 2011 (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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251771

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

Additional Information:
Protocol Reviews in the Lancet.com  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00251771     History of Changes
Other Study ID Numbers: 1.2005.650, EUDRACT No.2005-004486-42
Study First Received: November 9, 2005
Last Updated: April 18, 2011
Health Authority: Norway: Directorate of Health

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

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

ClinicalTrials.gov processed this record on June 17, 2013