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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
Randomised, double blind trial in non-intensive care trauma patients comparing unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) in heparin-induced thrombocytopenia (HIT).
This is a randomised, double blind trial including trauma patients with need for thrombosis prophylaxis with heparin. Patients receive either unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH).
Heparin-induced thrombocytopenia (HIT) antibodies are measured on days 1 and 10. There are daily platelet counts. On discharge an ultrasound doppler of the lower extremities is performed to rule out deep vein thrombosis (DVT).
Three months after discharge every patient is answering a questionnaire about thromboembolic complications following discharge.
The key questions of the study are whether the two heparins cause HIT-antibodies in differing frequencies, and if yes, whether these differences lead to different clinical outcomes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard heparin (UFH) versus certoparin (LMWH) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients |
| Measure | Description | Time Frame |
|---|---|---|
| Thromboembolic complications (TECs) during inpatient period in relation to heparin received and HIT-antibody status | ||
| TECs during 3 months following discharge in relation to heparin received and HIT-antibody status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Greinacher, Prof. Dr. | Ernst-Moritz-Arndt University Greifswald, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ernst-Moritz-Arndt University, Depts. of Transfusion Medicine / Trauma surgery | Greifswald | 17489 | Germany |
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| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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