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

Sponsor

Aalborg University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00628576

Collaborator

Aalborg University (Other)

Enrollment

Location

Arms

128

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Deep Venous Thrombosis	Drug: unfractionated heparin Drug: Tinzaparin (Leo)	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 1993

Actual Primary Completion Date :

Jun 1, 2004

Actual Study Completion Date :

Jun 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 UFH: patients treated with unfractionated heparin	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
Experimental: 2 FH: patients treated with low-molecular-weight (fractionated) heparin	Drug: Tinzaparin (Leo) FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily Other Names: Innohep (Leo)

Arm

Intervention/Treatment

Active Comparator: 1

UFH: patients treated with unfractionated heparin

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

Experimental: 2

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

Drug: Tinzaparin (Leo)

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

Other Names:

Innohep (Leo)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.