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

Aalborg University Hospital99 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Deep Venous Thrombosis

Interventions

unfractionated heparinDRUG

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)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dept. of Haematology; Aalborg Hospital

Aalborg, North Denmark, Denmark

Outcomes

Primary Outcomes

Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.

Time frame: Two years and 6 to 10 years

Data from ClinicalTrials.gov

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