Back to resultsEvaluation of Long-Term Sequelae After Thrombophlebitis, i.e. Deep Venous Thrombosis of the Lower Extremities
Primary Purpose
Deep Venous Thrombosis
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
unfractionated heparin
Tinzaparin (Leo)
Sponsored by
About this trial
This is an interventional treatment trial for Deep Venous Thrombosis focused on measuring Deep Venous Thrombosis, lower extremities, Chronic Venous Insufficiency, Postthrombotic Syndrome, Heparins, Low-molecular- weight heparin, Tinzaparin
Eligibility 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.
Sites / Locations
- Dept. of Haematology; Aalborg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
UFH: patients treated with unfractionated heparin
FH: patients treated with low-molecular-weight (fractionated) heparin
Outcomes
Primary Outcome Measures
Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.
Secondary Outcome Measures
Full Information
NCT ID
NCT00628576
First Posted
February 25, 2008
Last Updated
February 26, 2008
Sponsor
Aalborg University Hospital
Collaborators
Aalborg University
1. Study Identification
Unique Protocol Identification Number
NCT00628576
Brief Title
Evaluation of Long-Term Sequelae After Thrombophlebitis, i.e. Deep Venous Thrombosis of the Lower Extremities
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 Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
October 1993 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Aalborg University Hospital
Collaborators
Aalborg University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Venous Thrombosis
Keywords
Deep Venous Thrombosis, lower extremities, Chronic Venous Insufficiency, Postthrombotic Syndrome, Heparins, Low-molecular- weight heparin, Tinzaparin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
UFH: patients treated with unfractionated heparin
Arm Title
2
Arm Type
Experimental
Arm Description
FH: patients treated with low-molecular-weight (fractionated) heparin
Intervention Type
Drug
Intervention Name(s)
unfractionated heparin
Other Intervention Name(s)
Heparin SAD 1000 IU/ml
Intervention Description
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
Intervention Name(s)
Tinzaparin (Leo)
Other Intervention Name(s)
Innohep (Leo)
Intervention Description
FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily
Primary Outcome Measure Information:
Title
Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria.
Time Frame
Two years and 6 to 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedicte Laursen, MD, DMSc
Organizational Affiliation
Department of Haematology; Aalborg Hospital, 9100 Aalborg, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Haematology; Aalborg Hospital
City
Aalborg
State/Province
Region Nordjylland
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Long-Term Sequelae After Thrombophlebitis, i.e. Deep Venous Thrombosis of the Lower Extremities
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