Prospective study of the clinical outcome of immediate and maintenance treatment of deep leg and pelvic vein thrombosis for various risk factors

Prospective study of the clinical outcome of immediate and maintenance treatment of deep leg and pelvic vein thrombosis for various risk factors - TVT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00018104

Enrollment

100

Registered

2019-10-10

Start date

2019-02-19

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

I80.20 I80.2

Interventions

Group 1: In this study app. 100 patients with deep leg or pelvic vein thrombosis (DVT) should be included. Aim of the study is to investigate the influence of different risk factors on the clinical ou

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - patients with deep leg and pelvic vein thrombosis (diagnosis since July 2018) - patients with rezidiv - signed consent form

Exclusion criteria

Exclusion criteria: - no signed consent form - patients, whose reduced general condition does not seem to make maintenance therapy after 3 months reasonable

Design outcomes

Primary

Measure	Time frame
Outcome: time period until occurence of combined negative event: spread of TVT, embolism, rezidiv, thrombosis, bleeding event, morbidity, mortality	—

Secondary

Measure	Time frame
Kind of therapy: - Acute therapy (if yes, which: low molecular heparin (NMH), Fondaparinux, UF-heparine, direct oral anticoagulants (DOAK), Vitamin-K-antagonists (VKS) - maintenance therapy (yes/no, which: longer than 3 months post acute therapy start: low molecular heparin (NMH), Fondaparinux, UF-heparine, direct oral anticoagulants (DOAK) - use of "criteria for / against a prolonged maintenance therapy with anticoagulants" - time period until single event of a combined primary outcome event - risk factors (prior immobilization or surgical intervention, Adipositas, thrombophilia, heart insufficiency, malignem, hormone therapy, pregnancy, prior bleeding or thrombosis events, bleeding risk (HAS-BLED-Score) - Co-therapy (physiotherapy, mobilisation, elevation of legs, tights, compression) - demography (age, gender) - anamnesis TVT/PE (date/localisation/grade) - Co-morbidities and Co-medication Data will be collected from patients´records and by questionnaires for the physicians (month 0 and 12). - 3 months post DVT: ultrasound in angiology and thrombophilia screening. - 12 months post DVT: ultrasound and vein-occlusion-plethysmography	—

Measure

Time frame

Kind of therapy: - Acute therapy (if yes, which: low molecular heparin (NMH), Fondaparinux, UF-heparine, direct oral anticoagulants (DOAK), Vitamin-K-antagonists (VKS) - maintenance therapy (yes/no, which: longer than 3 months post acute therapy start: low molecular heparin (NMH), Fondaparinux, UF-heparine, direct oral anticoagulants (DOAK) - use of "criteria for / against a prolonged maintenance therapy with anticoagulants" - time period until single event of a combined primary outcome event - risk factors (prior immobilization or surgical intervention, Adipositas, thrombophilia, heart insufficiency, malignem, hormone therapy, pregnancy, prior bleeding or thrombosis events, bleeding risk (HAS-BLED-Score) - Co-therapy (physiotherapy, mobilisation, elevation of legs, tights, compression) - demography (age, gender) - anamnesis TVT/PE (date/localisation/grade) - Co-morbidities and Co-medication Data will be collected from patients´records and by questionnaires for the physicians (month 0 and 12). - 3 months post DVT: ultrasound in angiology and thrombophilia screening. - 12 months post DVT: ultrasound and vein-occlusion-plethysmography

—

Countries

Germany

Contacts

Public ContactWolfgang Miesbach

Hämophiliezentrum, Institut für Transfusionsmedizin, Medizinische Klinik III, Goethe Universitätsklinikum

wolfgang.miesbach@kgu.de06963015051

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026