Evaluation of Long-Term Sequelae After Thrombophlebitis, i.e. Deep Venous Thrombosis of the Lower Extremities
Information source: Aalborg Universitetshospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Deep Venous Thrombosis
Intervention: unfractionated heparin (Drug); Tinzaparin (Leo) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Aalborg Universitetshospital Official(s) and/or principal investigator(s): Benedicte Laursen, MD, DMSc, Principal Investigator, Affiliation: Department of Haematology; Aalborg Hospital, 9100 Aalborg, Denmark
Summary
The purpose of the study was to evaluate efficacy and safety of the new acute treatment of
deep venous thrombosis by use of low-molecular-weight heparin compared with standard
treatment using unfractionated heparin, especially concerning long-term morbidity.
Clinical Details
Official title: Deep Venous Thrombosis. Long-Term Results After Treatment With Either Low-Molecular -Weight Heparin or Unfractionated Heparin. Examinations of the Venous System.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.
Detailed description:
Deep-venous thrombosis (DVT) remains a common clinical problem (annual incidence 0. 10-0. 16%)
and long-term morbidity as chronic venous insufficience (CVI) in 10-30%.
As to recurrent DVT, initial treatment with Low-Molecular-Weight Heparin ( to-day's
terminology Fractionated Heparin (FH)) and Unfractionated Heparin (UFH) has shown equal
efficiency, whereas the efficacy concerning long-term morbidity has only more recently been
published.
This study was initiated to compare the efficacy of UFH and FH concerning the incidence of
CVI after symptomatic DVT at short-term and long-term follow-up.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- First DVT with or without known risk factors except overt cancer
- Second DVT more than two years after the first if the patient was without clinical
signs of CVI.
Exclusion Criteria:
- Contraindication to anticoagulation therapy
- Candidate to thrombectomy with arterious-venous fistula or thrombolytic therapy
- Known cancer at the time of the DVT diagnosis
- Patients unable to cooperate for anticoagulation therapy or manage the tests.
Locations and Contacts
Dept. of Haematology; Aalborg Hospital, Aalborg, Region Nordjylland 9000, Denmark
Additional Information
Starting date: October 1993
Last updated: February 26, 2008
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