An interventional study of catheter-directed venous thrombolysis in Deep Vein Thrombosis, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-04-30.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
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%.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 209 is above the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Patency after 6 months
Time frame: 6 months
Post-thrombotic syndrome after 2 years (yrs)
Time frame: 2 years
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
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital