Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis
Norway209 participantsStarted 2006-01
Plain-language 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%.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.