Evaluation of Long-Term Sequelae After Thrombophlebitis, i.e. Deep Venous Thrombosis of the Lower Extremities

Last updated: February 26, 2008
Sponsor: Aalborg University Hospital
Overall Status: Completed

Phase

3

Condition

Venous Thrombosis

Claudication

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT00628576
VN 2003/15 (2-16-4 - 0001- 03)
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 clinicalsigns of CVI.

Exclusion

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.

Study Design

Total Participants: 99
Study Start date:
October 01, 1993
Estimated Completion Date:
June 30, 2004

Study 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.

Connect with a study center

  • Dept. of Haematology; Aalborg Hospital

    Aalborg, Region Nordjylland 9000
    Denmark

    Site Not Available

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