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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

Page last updated: August 23, 2015

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