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

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ClinicalTrials.gov Identifier: NCT00628576
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : March 5, 2008
Sponsor:
Collaborator:
Aalborg University
Information provided by:
Aalborg Universitetshospital

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.

Condition or disease Intervention/treatment Phase
Deep Venous Thrombosis Drug: unfractionated heparin Drug: Tinzaparin (Leo) Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 1993
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
UFH: patients treated with unfractionated heparin
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

Experimental: 2
FH: patients treated with low-molecular-weight (fractionated) heparin
Drug: Tinzaparin (Leo)
FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily
Other Name: Innohep (Leo)




Primary Outcome Measures :
  1. Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria. [ Time Frame: Two years and 6 to 10 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628576


Locations
Denmark
Dept. of Haematology; Aalborg Hospital
Aalborg, Region Nordjylland, Denmark, 9000
Sponsors and Collaborators
Aalborg Universitetshospital
Aalborg University
Investigators
Principal Investigator: Benedicte Laursen, MD, DMSc Department of Haematology; Aalborg Hospital, 9100 Aalborg, Denmark

Responsible Party: Principal investigator: Benedicte Laursen MD, DMSc, Department of Haematology and Medicine Aalborg Hospital, 9100 Aalborg, Denmark
ClinicalTrials.gov Identifier: NCT00628576     History of Changes
Other Study ID Numbers: VN 2003/15 (2-16-4 - 0001- 03)
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: March 5, 2008
Last Verified: February 2008

Keywords provided by Aalborg Universitetshospital:
Deep Venous Thrombosis
lower extremities
Chronic Venous Insufficiency
Postthrombotic Syndrome
Heparins
Low-molecular- weight heparin
Tinzaparin

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Tinzaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action