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

Tracking Information

First Received Date ^ICMJE

February 25, 2008

Last Updated Date

February 26, 2008

Start Date ^ICMJE

October 1993

Primary Completion Date

June 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00628576 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Deep Venous Thrombosis

Intervention ^ICMJE

Drug: unfractionated heparin
Drug: Tinzaparin (Leo)

Study Arms / Comparison Groups

Active Comparator: UFH: patients treated with unfractionated heparin
Experimental: FH: patients treated with low-molecular-weight (fractionated) heparin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2004

Primary Completion Date

June 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00628576

Responsible Party

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

Study ID Numbers ^ICMJE

VN 2003/15 (2-16-4 - 0001- 03)

Study Sponsor ^ICMJE

Aalborg Hospital

Collaborators ^ICMJE

Aalborg University

Investigators ^ICMJE

Principal Investigator:

Benedicte Laursen, MD, DMSc

Department of Haematology; Aalborg Hospital, 9100 Aalborg, Denmark

Information Provided By

Aalborg Hospital

Verification Date

February 2008

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