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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014