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Completed

NCT Number: NCT00628576

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

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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Key information

Conditions

Deep Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Postthrombotic Syndrome Thrombosis Vascular Diseases Venous Insufficiency Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dept. of Haematology; Aalborg Hospital

Aalborg, North Denmark, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Unfractionated heparin

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

Other names: Heparin SAD 1000 IU/ml

Tinzaparin (Leo)

Drug

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

Other names: Innohep (Leo)

Primary outcomes

  1. Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.

    Time frame: Two years and 6 to 10 years

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Aalborg University

Registry information

Official study title

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

Important dates

Study start
1993
Primary completion
2004
Study completion
2004
First posted
Mar 5, 2008
Registry last updated
Mar 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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