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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Deep Venous Thrombosis

Intervention / Treatment
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* Drug: unfractionated heparin
* Drug: Tinzaparin (Leo)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>UFH: patients treated with unfractionated heparin | Drug: unfractionated heparin<br>* 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<br>* Other names: Heparin SAD 1000 IU/ml;|
| Experimental: 2<br>FH: patients treated with low-molecular-weight (fractionated) heparin | Drug: Tinzaparin (Leo)<br>* FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily<br>* Other names: Innohep (Leo);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria. |  | Two years and 6 to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Venous Thrombosis, lower extremities, Chronic Venous Insufficiency, Postthrombotic Syndrome, Heparins, Low-molecular- weight heparin, Tinzaparin