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

Phase 3

Completed

• Conditions: Deep Venous Thrombosis
• Interventions: Drug: unfractionated heparin; Drug: Tinzaparin (Leo)

• Registration Number: NCT00628576
• Lead Sponsor: Aalborg University Hospital

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 Timeline

• Study Start: 1993-10
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Status Verified: 2008-02
• Study First Submitted: 2008-02-25
• Study First Submitted QC: 2008-02-26
• Last Update Submitted: 2008-02-26
• Study First Posted: 2008-03-05
• Last Update Posted: 2008-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	unfractionated heparin	UFH: patients treated with unfractionated heparin
2	Tinzaparin (Leo)	FH: patients treated with low-molecular-weight (fractionated) heparin

Primary Outcome Measures

Name	Time	Method
Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.	Two years and 6 to 10 years

Trial Locations

Locations (1)

Dept. of Haematology; Aalborg Hospital; 🇩🇰 Aalborg, Region Nordjylland, Denmark