Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis

Deep Vein Thrombosis Clinical Trial

— CaVenT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251771
• Other study ID #: 1.2005.650
• Secondary ID: EUDRACT No.2005-
• Status: Completed
• Phase: N/A
• First received: November 9, 2005
• Last updated: April 29, 2015
• Start date: January 2006
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Interventional

Clinical Trial Summary

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
Norway	Ullevaal University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Hospital Ostfold, Fredrikstad

Country where clinical trial is conducted

Norway, 

References & Publications (10)

Enden T, Garratt AM, Kløw 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. — View Citation

Enden T, Haig Y, Kløw NE, Slagsvold CE, Sandvik L, Ghanima W, Hafsahl G, Holme PA, Holmen LO, Njaastad AM, Sandbæk G, Sandset PM; CaVenT Study Group. Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute ili — View Citation

Enden T, Kløw NE, Sandset PM. [Catheter-directed thrombolysis in acute deep venous thrombosis]. Tidsskr Nor Laegeforen. 2006 Jun 22;126(13):1765. Norwegian. — View Citation

Enden T, Kløw 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. — View Citation

Enden T, Kløw 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 rando — View Citation

Enden T, Resch S, White C, Wik HS, Kløw 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. — View Citation

Enden T, Sandset PM, Kløw 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. English, Norwegian. — View Citation

Enden T, Sandvik L, Kløw 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. Epub 2007 Sep 6. — View Citation

Enden T, Wik HS, Kvam AK, Haig Y, Kløw 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) — View Citation

Haig Y, Enden T, Slagsvold CE, Sandvik L, Sandset PM, Kløw 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.2012.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency after 6 months		6 months	No
Primary	Post-thrombotic syndrome after 2 years (yrs)		2 years	No
Secondary	Frequency of clinically relevant bleeding complications		1 year	Yes
Secondary	Effects on quality of life		2 and 5 years	No
Secondary	Cost-effectiveness of treatment		2 years	No
Secondary	Procedural success of CDT		1 week	No
Secondary	Patency at 2 years		2 years	No
Secondary	PTS at 6, 12, 36, 48 and 60 months		6, 12, 36, 48 and 60 months	No
Secondary	Relation between PTS and patency		2 years	No
Secondary	Prevalence of vein anomalies		6 months	No
Secondary	Prevalence of underlying thrombophilia		1 year	No
Secondary	Frequency of recurrent venous thrombotic events (VTE)		0.5, 2 and 5 years	Yes
Secondary	Markers of importance for recurrent thrombosis		0.5, 2 and 5 years	No
Secondary	Markers of importance for successful thrombolysis		2 years	No

External Links

•   Protocol Reviews in the Lancet.com