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

Overview

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.

Full Title of Study: “Deep Venous Thrombosis. Long-Term Results After Treatment With Either Low-Molecular -Weight Heparin or Unfractionated Heparin. Examinations of the Venous System.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2004

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.

Interventions

  • Drug: unfractionated heparin
    • UFH: Continuous i.v. infusion 100 IU/kg/4hrs initially and then adjusted to maintain APTT value 1.5 – 2.5 the pre-treatment value
  • Drug: Tinzaparin (Leo)
    • FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily

Arms, Groups and Cohorts

  • Active Comparator: 1
    • UFH: patients treated with unfractionated heparin
  • Experimental: 2
    • FH: patients treated with low-molecular-weight (fractionated) heparin

Clinical Trial Outcome Measures

Primary Measures

  • Clinical evaluation of chronic venous insufficiency (CVI) – (Postthrombotic Syndrome) based on internationally accepted criteria.
    • Time Frame: Two years and 6 to 10 years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aalborg University Hospital
  • Collaborator
    • Aalborg University
  • Provider of Information About this Clinical Study
    • Principal investigator: Benedicte Laursen MD, DMSc, Department of Haematology and Medicine Aalborg Hospital, 9100 Aalborg, Denmark
  • Overall Official(s)
    • Benedicte Laursen, MD, DMSc, Principal Investigator, Department of Haematology; Aalborg Hospital, 9100 Aalborg, Denmark

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