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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT No.2005-004486-42 |
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| Name | Class |
|---|---|
| Ostfold Hospital Trust | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental |
| |
| II | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patency after 6 months | 6 months | |
| Post-thrombotic syndrome after 2 years (yrs) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of clinically relevant bleeding complications | 1 year | |
| Effects on quality of life | 2 and 5 years | |
| Cost-effectiveness of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Morten Sandset, MD | Ullevaal University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ullevaal University Hospital | Oslo | Oslo | 0407 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16794675 | Background | Enden T, Klow NE, Sandset PM. [Catheter-directed thrombolysis in acute deep venous thrombosis]. Tidsskr Nor Laegeforen. 2006 Jun 22;126(13):1765. No abstract available. Norwegian. | |
| 17967583 | Background | Enden T, Sandvik L, Klow NE, Hafsahl G, Holme PA, Holmen LO, Ghanima W, Njaastad AM, Sandbaek G, Slagsvold CE, Sandset PM. Catheter-directed Venous Thrombolysis in acute iliofemoral vein thrombosis--the CaVenT study: rationale and design of a multicenter, randomized, controlled, clinical trial (NCT00251771). Am Heart J. 2007 Nov;154(5):808-14. doi: 10.1016/j.ahj.2007.07.010. Epub 2007 Sep 6. |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011186 | Postphlebitic Syndrome |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 2 years |
| Procedural success of CDT | 1 week |
| Patency at 2 years | 2 years |
| PTS at 6, 12, 36, 48 and 60 months | 6, 12, 36, 48 and 60 months |
| Relation between PTS and patency | 2 years |
| Prevalence of vein anomalies | 6 months |
| Prevalence of underlying thrombophilia | 1 year |
| Frequency of recurrent venous thrombotic events (VTE) | 0.5, 2 and 5 years |
| Markers of importance for recurrent thrombosis | 0.5, 2 and 5 years |
| Markers of importance for successful thrombolysis | 2 years |
| 19068041 | Background | Enden T, Garratt AM, Klow NE, Sandset PM. Assessing burden of illness following acute deep vein thrombosis: data quality, reliability and validity of the Norwegian version of VEINES-QOL/Sym, a disease-specific questionnaire. Scand J Caring Sci. 2009 Jun;23(2):369-74. doi: 10.1111/j.1471-6712.2008.00618.x. Epub 2008 Nov 12. |
| 22669381 | Background | Enden T, Sandset PM, Klow NE. Evidence-based practice for patients with severe venous thrombosis. Tidsskr Nor Laegeforen. 2012 May 29;132(10):1215-6. doi: 10.4045/tidsskr.12.0474. No abstract available. English, Norwegian. |
| 19422443 | Result | Enden T, Klow NE, Sandvik L, Slagsvold CE, Ghanima W, Hafsahl G, Holme PA, Holmen LO, Njaastad AM, Sandbaek G, Sandset PM; CaVenT study group. Catheter-directed thrombolysis vs. anticoagulant therapy alone in deep vein thrombosis: results of an open randomized, controlled trial reporting on short-term patency. J Thromb Haemost. 2009 Aug;7(8):1268-75. doi: 10.1111/j.1538-7836.2009.03464.x. Epub 2009 Apr 30. |
| 22172244 | Result | Enden T, Haig Y, Klow NE, Slagsvold CE, Sandvik L, Ghanima W, Hafsahl G, Holme PA, Holmen LO, Njaastad AM, Sandbaek G, Sandset PM; CaVenT Study Group. Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial. Lancet. 2012 Jan 7;379(9810):31-8. doi: 10.1016/S0140-6736(11)61753-4. Epub 2011 Dec 13. |
| 23176966 | Result | Haig Y, Enden T, Slagsvold CE, Sandvik L, Sandset PM, Klow NE. Determinants of early and long-term efficacy of catheter-directed thrombolysis in proximal deep vein thrombosis. J Vasc Interv Radiol. 2013 Jan;24(1):17-24; quiz 26. doi: 10.1016/j.jvir.2012.09.023. Epub 2012 Nov 22. |
| 23452204 | Result | Enden T, Resch S, White C, Wik HS, Klow NE, Sandset PM. Cost-effectiveness of additional catheter-directed thrombolysis for deep vein thrombosis. J Thromb Haemost. 2013 Jun;11(6):1032-42. doi: 10.1111/jth.12184. |
| 23988361 | Result | Enden T, Wik HS, Kvam AK, Haig Y, Klow NE, Sandset PM. Health-related quality of life after catheter-directed thrombolysis for deep vein thrombosis: secondary outcomes of the randomised, non-blinded, parallel-group CaVenT study. BMJ Open. 2013 Aug 29;3(8):e002984. doi: 10.1136/bmjopen-2013-002984. |
| 24082798 | Result | Enden T, Klow NE, Sandset PM. Symptom burden and job absenteeism after treatment with additional catheter-directed thrombolysis for deep vein thrombosis. Patient Relat Outcome Meas. 2013 Sep 16;4:55-9. doi: 10.2147/PROM.S47233. eCollection 2013. |
| 39968829 | Derived | Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2. |
| 33464575 | Derived | Broderick C, Watson L, Armon MP. Thrombolytic strategies versus standard anticoagulation for acute deep vein thrombosis of the lower limb. Cochrane Database Syst Rev. 2021 Jan 19;1(1):CD002783. doi: 10.1002/14651858.CD002783.pub5. |
| 26853645 | Derived | Haig Y, Enden T, Grotta O, Klow NE, Slagsvold CE, Ghanima W, Sandvik L, Hafsahl G, Holme PA, Holmen LO, Njaaastad AM, Sandbaek G, Sandset PM; CaVenT Study Group. Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial. Lancet Haematol. 2016 Feb;3(2):e64-71. doi: 10.1016/S2352-3026(15)00248-3. Epub 2016 Jan 6. |
| D010689 |
| Phlebitis |
| D016491 | Peripheral Vascular Diseases |
| D014689 | Venous Insufficiency |