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NCT Number: NCT00251771

Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis

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%.

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis Peripheral Vascular Diseases Phlebitis Postphlebitic Syndrome Thrombosis Vascular Diseases Venous Insufficiency Venous Thrombosis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ullevaal University Hospital

Oslo, 0407, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

catheter-directed venous thrombolysis

Procedure

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.

Primary outcomes

  1. Patency after 6 months

    Time frame: 6 months

  2. Post-thrombotic syndrome after 2 years (yrs)

    Time frame: 2 years

Secondary outcomes

  1. Frequency of clinically relevant bleeding complications

    Time frame: 1 year

  2. Effects on quality of life

    Time frame: 2 and 5 years

  3. Cost-effectiveness of treatment

    Time frame: 2 years

  4. Procedural success of CDT

    Time frame: 1 week

  5. Patency at 2 years

    Time frame: 2 years

  6. PTS at 6, 12, 36, 48 and 60 months

    Time frame: 6, 12, 36, 48 and 60 months

  7. Relation between PTS and patency

    Time frame: 2 years

  8. Prevalence of vein anomalies

    Time frame: 6 months

  9. Prevalence of underlying thrombophilia

    Time frame: 1 year

  10. Frequency of recurrent venous thrombotic events (VTE)

    Time frame: 0.5, 2 and 5 years

  11. Markers of importance for recurrent thrombosis

    Time frame: 0.5, 2 and 5 years

  12. Markers of importance for successful thrombolysis

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Ostfold Hospital Trust

Registry information

Official study title

Catheter-directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis, an Open Randomized, Controlled, Clinical Trial

Acronym: CaVenT

Important dates

Study start
2006
Primary completion
2014
Study completion
2014
First posted
Nov 10, 2005
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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