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

Aalborg University Hospital

Status and phase: Completed; Phase 3

Conditions: Deep Venous Thrombosis

Treatments: Drug: unfractionated heparin; Drug: Tinzaparin (Leo)

Study type: Interventional

Funder types: Other

Identifiers

NCT00628576

VN 2003/15 (2-16-4 - 0001- 03)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

1

Active Comparator group

Description:

UFH: patients treated with unfractionated heparin

Treatment:

Drug: unfractionated heparin

2

Experimental group

Description:

FH: patients treated with low-molecular-weight (fractionated) heparin

Treatment:

Drug: Tinzaparin (Leo)