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Prospective study to the Optimal duration of Compression Therapy As prevention of chronic Venous Insufficiency After deep venous thrombosis

Prospective study to the Optimal duration of Compression Therapy As prevention of chronic Venous Insufficiency After deep venous thrombosis - OCTAVIA-study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35400
Enrollment
516
Registered
2009-01-19
Start date
2009-02-17
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-thrombotic syndrome

Interventions

Two groups: 1) continuing ACT for another year
2) no ACT in second year post-DVT.

Sponsors

Diakonessenhuis Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: all patients with one year adequate therapy after echo duplex proven proximal DVT of the leg informed consent

Exclusion criteria

Exclusion criteria: recurrent ipsilateral DVT (known riskfactor of PTS) PTS developped in first year post-thrombosis DVT only distal of popliteal vein contra-indication for (stopping) compression therapy as indicated by treating physician no informed consent

Design outcomes

Primary

MeasureTime frame
Primary outcome: - The incidence of PTS in the second post-thrombotic year after one versus two years of ambulant compression therapy

Secondary

MeasureTime frame
Secundary outcomes: - Can venous ultrasound discriminate between patients after one year ACT in risk of developing PTS - Can baseline characteristics be used as prognostic markers for developing PTS - What influence does (the absense of) ACT and PTS has on quality of life

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)