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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 Universityhospital
ClinicalTrials.gov Identifier:
NCT00628576
First received: February 25, 2008
Last updated: February 26, 2008
Last verified: February 2008
History of Changes
  Purpose

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 Intervention Phase
Deep Venous Thrombosis
 Drug: unfractionated heparin
Drug: Tinzaparin (Leo)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 99
Study Start Date: October 1993
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628576

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

No publications provided

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)
Study First Received: February 25, 2008
Last Updated: February 26, 2008
Health Authority: Denmark: National Board of Health

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

Additional relevant MeSH terms:
Thrombophlebitis
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Phlebitis
Peripheral Vascular Diseases
Vasculitis
Thromboembolism
Calcium heparin
 Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Tinzaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 13, 2013