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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

November 9, 2005
April 18, 2011
January 2006
December 2011   (final data collection date for primary outcome measure)
  • Patency after 6 months [ Time Frame: 6 months ]
  • Post-thrombotic syndrome after 2 years (yrs) [ Time Frame: 2 years ]
  • Patency after 6 months.
  • Postthrombotic syndrome after 2 yrs.
Complete list of historical versions of study NCT00251771 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To investigate:
  • Frequency of clincally relevant bleeding complications
  • Effects on qualitiy of life
  • Cost-effectiveness of treatment
  • Procedural success of CDT
  • Markers of importance for successful thrombolysis
  • Patency at 2 yrs
  • PTS at 6,12,36,48 and 60 months
  • Relation between PTS and patency
  • Prevalence of vein anomalies
  • Prevalence of underlying thrombophilia
  • Frequency of recurrent VTE
  • Markers of importance for recurrent thrombosis
Not Provided
Not Provided
 
Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis
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%.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Deep Vein Thrombosis
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.
  • Experimental: I
    Intervention: Procedure: catheter-directed venous thrombolysis
  • No Intervention: II

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
January 2017
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00251771
1.2005.650, EUDRACT No.2005-004486-42
Yes
Not Provided
Ullevaal University Hospital
  • University Hospital, Aker
  • Oslo University Hospital
  • Hospital Ostfold, Fredrikstad
Study Director: Per Morten Sandset, MD Ullevaal University Hospital
Oslo University Hospital
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP