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

Sponsor:	Aalborg Hospital
Collaborator:	Aalborg University
Information provided by:	Aalborg Hospital
ClinicalTrials.gov Identifier:	NCT00628576

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis

Drug Information available for: Heparin

U.S. FDA Resources

Further study details as provided by Aalborg Hospital:

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

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, Region Nordjylland
Dept. of Haematology; Aalborg Hospital
Aalborg, Region Nordjylland, Denmark, 9000

Sponsors and Collaborators

Aalborg Hospital

Aalborg University

Investigators

Principal Investigator:

Benedicte Laursen, MD, DMSc

Department of Haematology; Aalborg Hospital, 9100 Aalborg, Denmark

More Information

No publications provided

Responsible Party:	Department of Haematology and Medicine Aalborg Hospital, 9100 Aalborg, Denmark ( Principal investigator: Benedicte Laursen MD, DMSc )
Study ID Numbers:	VN 2003/15 (2-16-4 - 0001- 03)
Study First Received:	February 25, 2008
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00628576 History of Changes
Health Authority:	Denmark: National Board of Health

Keywords provided by Aalborg Hospital:

Deep Venous Thrombosis
lower extremities
Chronic Venous Insufficiency
Postthrombotic Syndrome

Heparins
Low-molecular- weight heparin
Tinzaparin

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Heparin, Low-Molecular-Weight
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Thrombosis
Pharmacologic Actions

Calcium heparin
Embolism and Thrombosis
Fibrin Modulating Agents
Therapeutic Uses
Tinzaparin
Venous Thrombosis
Cardiovascular Diseases
Heparin

ClinicalTrials.gov processed this record on November 27, 2009