This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

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

Resource links provided by NLM:

Further study details as provided by Aalborg Universitetshospital:

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 ]

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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00628576

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

Responsible Party: Principal investigator: Benedicte Laursen MD, DMSc, Department of Haematology and Medicine Aalborg Hospital, 9100 Aalborg, Denmark 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

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

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 17, 2017