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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-10-31

Study Completion Date

2004-06-30

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.

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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.

Conditions

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Deep Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

UFH: patients treated with unfractionated heparin

Group Type ACTIVE_COMPARATOR

unfractionated heparin

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Tinzaparin (Leo)

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Tinzaparin (Leo)

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

Intervention Type DRUG

Other Intervention Names

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Heparin SAD 1000 IU/ml Innohep (Leo)

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No