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Optimal duration of Compression Therapy As prevention of chronic Venous Insufficiency After deep venous thrombosis


- candidate number3916
- NTR NumberNTR1442
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-sep-2008
- Secondary IDs0801-60 Fonds NutsOhra 
- Public TitleOptimal duration of Compression Therapy As prevention of chronic Venous Insufficiency After deep venous thrombosis
- Scientific TitleOptimal duration of Compression Therapy As prevention of chronic Venous Insufficiency After deep venous thrombosis
- ACRONYMOCTAVIA
- hypothesisWe hypothesise that one year compression therapy after DVT is equally effective as two years in the prevention of the post-thrombotic syndrome - in selected patients.
- Healt Condition(s) or Problem(s) studiedDeep vein thrombosis , Elastic stockings , Venous insufficiency , Postthrombotic syndrome
- Inclusion criteria1. All patients with deep venous thrombosis who received one year of compression therapy.
- Exclusion criteria1. Recurrent ipsilateral DVT
2. Contra indication for (stopping) compression therapy
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2009
- planned closingdate31-dec-2010
- Target number of participants460
- InterventionsAt inclusion, patients will be randomized in two groups; one receiving a following year of compression therapy, one without.
- Primary outcome- The incidence of post-thrombotic syndrome in the second year of compression therapy.
- Secondary outcome- Evaluation of duplex ultrasound after one year compression therapy as predictive marker for PTS.
- Evaluation of baseline characteristics as predictive markers for PTS.
- Evaluation of quality of life (QoL)
- TimepointsT=0 randomization, duplex ultrasound, QoL
T=3 follow-up PTS (phone interview)
T=6 follow-up PTS (outpatient clinic)
T=12 follow-up PTS (outpatient clinic), QoL
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. G.C. Mol
- CONTACT for SCIENTIFIC QUERIESDr. M.A. Ree, van de
- Sponsor/Initiator Diakonessenhuis Utrecht, Department of Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
Fonds Nuts-Ohra
- PublicationsN/A
- Brief summaryProspective single-blind study to the optimal duration of ambulant compression therapy (ACT) after deep venous thrombosis as prevention of the post-thrombotic syndrome. After one year of ACT patients are randomized to either continuing ACT for a following year or stopping therapy. At inclusion, a blind duplex ultrasound is performed to evaluate its predictive value in PTS, as well as evaluation of baseline characteristics and laboratory findings. Quality of Life assessment is done at inclusion and after one year follow-up.
- Main changes (audit trail)
- RECORD4-sep-2008 - 19-sep-2008


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