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| ID | Type | Description | Link |
|---|---|---|---|
| Ethikkommission Luzern 542 | |||
| KSL 2006-1H |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Low molecular weight heparins (LMWH) have been shown to be at least as efficient and safe as unfractioned heparin (UFH) in prophylaxis and treatment of venous thromboembolic events and in therapy of acute cardiovascular diseases. LMWH are widely used as safe replacement of oral anticoagulation with vitamin K antagonists (VKA).
Due to their pharmacokinetic characteristics, LMWH tend to accumulate in patients with impaired renal function. Official guidelines recommend therefore to use LMWH controlled by Anti-Xa levels or to use UFH instead of LMWH to provide full therapeutic anticoagulation therapy in patients with severe renal insufficiency.
Although dosage recommendations have been proposed for enoxaparin in patients with renal impairment based on several studies, these data cannot be applied to other LMWH directly due to different pharmacokinetic properties of each drug.
The present study aims to clarify the pharmacokinetics of dalteparin in patients with renal insufficiency, especially addressing the question of accumulation after multiple doses and including patients with severe renal insufficiency and derive a safe and suitable concept for using dalteparin in patients with impaired renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P - A | Prophylactic Dosage, GFR >= 60 mL/min/1.73m^2 | ||
| P - B | Prophylactic Dosage, GFR 30-59 mL/min/1.73m^2 | ||
| P - C | Prophylactic Dosage, GFR < 30 mL/min/1.73m^2 | ||
| P - CAPD | Prophylactic Dosage, CAPD | ||
| T - A | Therapeutic Dosage, GFR >= 60 mL/min/1.73m^2 | ||
| T - B | Therapeutic Dosage, GFR 30-59 mL/min/1.73m^2 | ||
| T - C | Therapeutic Dosage, GFR < 30 mL/min/1.73m^2 | ||
| T - CAPD | Therapeutic Dosage, CAPD |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of a medical and surcigal department with all levels of renal function who needs Dalteparin for prophylaxis or therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Pirmin Schmid, MD | Luzerner Kantonsspital, Hematology | Principal Investigator |
| Andreas G Fischer, MD | Luzerner Kantonsspital, Nephrology | Study Director |
| Walter A Wuillemin, MD, PhD | Luzerner Kantonsspital, Hematology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Luzern | Lucerne | Canton of Lucerne | 6000 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19685350 | Background | Schmid P, Fischer AG, Wuillemin WA. Low-molecular-weight heparin in patients with renal insufficiency. Swiss Med Wkly. 2009 Aug 8;139(31-32):438-52. doi: 10.4414/smw.2009.11284. | |
| 19175499 | Result | Schmid P, Brodmann D, Fischer AG, Wuillemin WA. Study of bioaccumulation of dalteparin at a prophylactic dose in patients with various degrees of impaired renal function. J Thromb Haemost. 2009 Apr;7(4):552-8. doi: 10.1111/j.1538-7836.2009.03292.x. Epub 2009 Jan 19. |
| Label | URL |
|---|---|
| Luzerner Kantonsspital, Hematology | View source |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 19624460 | Result | Schmid P, Brodmann D, Odermatt Y, Fischer AG, Wuillemin WA. Study of bioaccumulation of dalteparin at a therapeutic dose in patients with renal insufficiency. J Thromb Haemost. 2009 Oct;7(10):1629-32. doi: 10.1111/j.1538-7836.2009.03556.x. Epub 2009 Jul 17. |
| 20088934 | Result | Schmid P, Brodmann D, Fischer AG, Wuillemin WA. Prospective observational cohort study of bioaccumulation of dalteparin at a prophylactic dose in patients with peritoneal dialysis. J Thromb Haemost. 2010 Apr;8(4):850-2. doi: 10.1111/j.1538-7836.2010.03749.x. Epub 2010 Jan 17. No abstract available. |
| Luzerner Kantonsspital, Nephrology | View source |
| Pirmin Schmid | View source |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |