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| Name | Class |
|---|---|
| Aalborg University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | UFH: patients treated with unfractionated heparin |
|
| 2 | Experimental | FH: patients treated with low-molecular-weight (fractionated) heparin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation of chronic venous insufficiency (CVI) - (Postthrombotic Syndrome) based on internationally accepted criteria. | Two years and 6 to 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benedicte Laursen, MD, DMSc | Department of Haematology; Aalborg Hospital, 9100 Aalborg, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Haematology; Aalborg Hospital | Aalborg | North Denmark | 9000 | Denmark |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D054070 | Postthrombotic Syndrome |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| D000078222 | Tinzaparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D006495 | Heparin, Low-Molecular-Weight |
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| Tinzaparin (Leo) | Drug | FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily |
|
|
| D014689 |
| Venous Insufficiency |