Deep Venous Thrombosis. Long-Term Results After Treatment With Either Low-Molecular -Weight Heparin or Unfractionated Heparin. Examinations of the Venous System.
Overview
- Phase
- Phase 3
- Intervention
- unfractionated heparin
- Conditions
- Deep Venous Thrombosis
- Sponsor
- Aalborg University Hospital
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief 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.
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.
Investigators
Eligibility 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.
Arms & Interventions
1
UFH: patients treated with unfractionated heparin
Intervention: unfractionated heparin
2
FH: patients treated with low-molecular-weight (fractionated) heparin
Intervention: Tinzaparin (Leo)
Outcomes
Primary Outcomes
Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.
Time Frame: Two years and 6 to 10 years