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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00628576

Enrollment

Registered

2008-03-05

Start date

1993-10-31

Completion date

2004-06-30

Last updated

2008-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Venous Thrombosis

Keywords

Deep Venous Thrombosis, lower extremities, Chronic Venous Insufficiency, Postthrombotic Syndrome, Heparins, Low-molecular- weight heparin, Tinzaparin

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.

Interventions

DRUGunfractionated 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

DRUGTinzaparin (Leo)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026