AzTrials
AzTrials

Deep Vein ThrombosisCaVenTNCT00251771

Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis

A study testing catheter-directed venous thrombolysis in people with Deep Vein Thrombosis, run by Oslo University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Deep Vein Thrombosis
What is being tested?
catheter-directed venous thrombolysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
209 participants
Where
1 siteNorway
Study dates
Jan 2006to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Onset of symptoms <21 days
  • Objectively verified DVT of the femoral or common iliac veins or the combined iliofemoral segment
  • Informed consent

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Ullevaal University Hospital

    Oslo, Oslo, 0407

Other trials in Norway

About this study

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

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%.

Being tested
catheter-directed venous thrombolysis
Keywords
Thrombolytic therapy, Postphlebitic syndrome, Venous thrombosis
Medical subject headings
Venous Thrombosis, Postphlebitic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • catheter-directed venous thrombolysisProcedure or surgery

    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 groups in NCT00251771
Study groupRoleWhat they receive
IExperimentalNot described
Receives: Procedure: catheter-directed venous thrombolysis
IINo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patency after 6 months

    Measured: 6 months

  2. Post-thrombotic syndrome after 2 years (yrs)

    Measured: 2 years

Secondary outcomes (12)

  1. Frequency of clinically relevant bleeding complications

    Measured: 1 year

  2. Effects on quality of life

    Measured: 2 and 5 years

  3. Cost-effectiveness of treatment

    Measured: 2 years

  4. Procedural success of CDT

    Measured: 1 week

  5. Patency at 2 years

    Measured: 2 years

  6. PTS at 6, 12, 36, 48 and 60 months

    Measured: 6, 12, 36, 48 and 60 months

  7. Relation between PTS and patency

    Measured: 2 years

  8. Prevalence of vein anomalies

    Measured: 6 months

  9. Prevalence of underlying thrombophilia

    Measured: 1 year

  10. Frequency of recurrent venous thrombotic events (VTE)

    Measured: 0.5, 2 and 5 years

  11. Markers of importance for recurrent thrombosis

    Measured: 0.5, 2 and 5 years

  12. Markers of importance for successful thrombolysis

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2005 (estimated)
  2. Study startJan 2006
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251771
Sponsor's protocol ID
1.2005.650
Other IDs
EUDRACT No.2005-004486-42
Acronym
CaVenT
Status last verified
Nov 2014
First submitted
9 Nov 2005
Last updated
30 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16794675

  • 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.

    PubMed 17967583

  • 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.

    PubMed 19068041

  • 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.

    PubMed 22669381

  • 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.

    PubMed 19422443

  • 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.

    PubMed 22172244

  • 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.

    PubMed 23176966

  • 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.

    PubMed 23452204

  • 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.

    PubMed 23988361

  • 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.

    PubMed 24082798

  • 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.

    PubMed 39968829

  • 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.

    PubMed 33464575

  • 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.

    PubMed 26853645

Questions about this trial

What is this clinical trial studying?

A study testing catheter-directed venous thrombolysis in people with Deep Vein Thrombosis, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patency after 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00251771, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in