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

This study has been completed.
Sponsor:
Collaborator:
Aalborg University
Information provided by:
Aalborg Universitetshospital
ClinicalTrials.gov Identifier:
NCT00628576
First received: February 25, 2008
Last updated: February 26, 2008
Last verified: February 2008

February 25, 2008
February 26, 2008
October 1993
June 2004   (final data collection date for primary outcome measure)
Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria. [ Time Frame: Two years and 6 to 10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00628576 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Long-Term Sequelae After Thrombophlebitis, i.e. Deep Venous Thrombosis of the Lower Extremities
Deep Venous Thrombosis. Long-Term Results After Treatment With Either Low-Molecular -Weight Heparin or Unfractionated Heparin. Examinations of the Venous System.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Deep Venous Thrombosis
  • 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
    Other Name: Heparin SAD 1000 IU/ml
  • Drug: Tinzaparin (Leo)
    FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily
    Other Name: Innohep (Leo)
  • Active Comparator: 1
    UFH: patients treated with unfractionated heparin
    Intervention: Drug: unfractionated heparin
  • Experimental: 2
    FH: patients treated with low-molecular-weight (fractionated) heparin
    Intervention: Drug: Tinzaparin (Leo)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
June 2004
June 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00628576
VN 2003/15 (2-16-4 - 0001- 03)
No
Principal investigator: Benedicte Laursen MD, DMSc, Department of Haematology and Medicine Aalborg Hospital, 9100 Aalborg, Denmark
Aalborg Universitetshospital
Aalborg University
Principal Investigator: Benedicte Laursen, MD, DMSc Department of Haematology; Aalborg Hospital, 9100 Aalborg, Denmark
Aalborg Universitetshospital
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP