Trial | NCT00628576  Report issue

Title

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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    heparin tinzaparin ...

  • Study Participants

    99
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.
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 Started
Oct 31
1993
Primary Completion
Jun 30
2004
Study Completion
Jun 30
2004
Last Update
Mar 05
2008
Estimate

Drug 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

  • Other names: Heparin SAD 1000 IU/ml

Drug Tinzaparin (Leo)

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

  • Other names: Innohep (Leo)

1 Active Comparator

UFH: patients treated with unfractionated heparin

2 Experimental

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

Criteria 

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.
No Results Posted