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

Deep Venous Thrombosis Clinical Trial

Official title:

Deep Venous Thrombosis. Long-Term Results After Treatment With Either Low-Molecular -Weight Heparin or Unfractionated Heparin. Examinations of the Venous System.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628576
• Other study ID #: VN 2003/15 (2-16-4 - 0001- 03)
• Status: Completed
• Phase: Phase 3
• First received: February 25, 2008
• Last updated: February 26, 2008
• Start date: October 1993
• Est. completion date: June 2004

Study information

• Verified date: February 2008
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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
• Tinzaparin (Leo)
FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily

Locations

Country	Name	City	State
Denmark	Dept. of Haematology; Aalborg Hospital	Aalborg	Region Nordjylland

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg Universitetshospital	Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.		Two years and 6 to 10 years	No