|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Aalborg Hospital Aalborg University |
| Information provided by: | Aalborg Hospital |
| ClinicalTrials.gov Identifier: | NCT00628576 |
Purpose
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 | Intervention | Phase |
|
Deep Venous Thrombosis |
Drug: unfractionated heparin Drug: Tinzaparin (Leo) |
Phase III |
| ChemIDplus related topics: | Heparin Benzocaine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Deep Venous Thrombosis. Long-Term Results After Treatment With Either Low-Molecular -Weight Heparin or Unfractionated Heparin. Examinations of the Venous System. |
| Enrollment: | 99 |
| Study Start Date: | October 1993 |
| Study Completion Date: | June 2004 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Active Comparator
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
|
|
2: Experimental
FH: patients treated with low-molecular-weight (fractionated) heparin
|
Drug: Tinzaparin (Leo)
FH (Tinzaparin): 175 iu/kg s.c. in the abdomen once daily
|
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark, Region Nordjylland | |||||
| Dept. of Haematology; Aalborg Hospital | |||||
| Aalborg, Region Nordjylland, Denmark, 9000 | |||||
| Aalborg Hospital |
| Aalborg University |
| Principal Investigator: | Benedicte Laursen, MD, DMSc | Department of Haematology; Aalborg Hospital, 9100 Aalborg, Denmark |
More Information
| Responsible Party: | Department of Haematology and Medicine Aalborg Hospital, 9100 Aalborg, Denmark ( Principal investigator: Benedicte Laursen MD, DMSc ) |
| Study ID Numbers: | VN 2003/15 (2-16-4 - 0001- 03) |
| First Received: | February 25, 2008 |
| Last Updated: | February 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00628576 |
| Health Authority: | Denmark: National Board of Health |
|
|
|
|
|
|