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

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

ChemIDplus related topics:

Heparin Benzocaine

U.S. FDA Resources

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.

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

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)
First Received:	February 25, 2008
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00628576
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

Study placed in the following topic categories:

Heparin, Low-Molecular-Weight

Vascular Diseases

Benzocaine

Postthrombotic Syndrome

Thrombosis

Calcium heparin

Body Weight

Embolism and Thrombosis

Embolism

Venous Insufficiency

Tinzaparin

Venous Thrombosis

Heparin

Postphlebitic Syndrome

Thrombophlebitis

Additional relevant MeSH terms:

Fibrin Modulating Agents

Anticoagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Aalborg Hospital Aalborg University
Information provided by:	Aalborg Hospital
ClinicalTrials.gov Identifier:	NCT00628576