Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis

Conditions

Deep Vein Thrombosis

Keywords

Thrombolytic therapy, Postphlebitic syndrome, Venous thrombosis

Brief 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%.

Haig Y, Enden T, Grøtta O, Kløw NE, Slagsvold CE, Ghanima W, Sandvik L, Hafsahl G, Holme PA, Holmen LO, Njaaastad AM, Sandbæk G, Sandset PM, CaVenT Study Group.

2016-01-06248 citations

10.1016/s2352-3026(15)00248-3

Tone Enden, Hilde Skuterud Wik, Ann Kristin Kvam, Ylva Haig, Nils Einar Kløw et al. (6 authors)

BMJ Open2013-08-01100 citations

10.1136/bmjopen-2013-002984

Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial.

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.

2011-12-13605 citations

10.1016/s0140-6736(11)61753-4

Interventions

PROCEDUREcatheter-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Patency after 6 months	6 months
Post-thrombotic syndrome after 2 years (yrs)	2 years

Secondary

Measure	Time frame
Frequency of clinically relevant bleeding complications	1 year
Effects on quality of life	2 and 5 years
Cost-effectiveness of treatment	2 years
Procedural success of CDT	1 week
Relation between PTS and patency	2 years
Patency at 2 years	2 years
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
Prevalence of vein anomalies	6 months
PTS at 6, 12, 36, 48 and 60 months	6, 12, 36, 48 and 60 months

Countries

Norway

Outcome results

None listed