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| ID | Type | Description | Link |
|---|---|---|---|
| Swissmedic 2006 DR 4 2 7 9 |
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Oral anticoagulation is often initiated in hospitalized patients. Although the therapeutic range of phenprocoumon is narrow, the individual drug demands unfortunately vary greatly between persons. Our group recently developed two dosing algorithms for the initiation of anticoagulation based on clinical predictors such as age, gender, body weight and laboratory values.
The aim of the proposed study is to prospectively evaluate the efficacy and safety of these two algorithms in medical and orthopedic inpatients, as well as in a group of outpatients and possibly in a geriatric collective.
Background:
The presently available oral anticoagulants have a very narrow therapeutic range but the interindividual demands to achieve therapeutic anticoagulation (=loading dose) varies greatly. Overanticoagulation is a major cause of bleeding complications, whereas insufficient anticoagulation is associated with thromboembolic disease and possibly prolonged hospital stay. A model to predict the loading dose with phenprocoumon (Marcoumar®) is therefore highly desirable.
In a retrospective analysis of 300 inpatients (152 medical, 148 orthopedic patients) of the Cantonal Hospital of St. Gallen our group identified clinical predictors for the loading dose of phenprocoumon and two dosing algorithms were developed (Good AC, Henz S. A clinical algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5.).
In order to validate the safety and efficacy of these dosing algorithms we plan this prospective interventional study with three equally sized arms: dosing according to algorithm 1, dosing according to algorithm 2 or dosing according to the estimate of the physician (control).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Algorithm which uses serum albumin and weight to determine the loading dose of phenprocoumon within the first 5 days |
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| B | Experimental | Algorithm which uses serum age and weight to determine the loading dose of phenprocoumon within the first 5 days |
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| C | Active Comparator | The physician chooses the loading dose of phenprocoumon according to his/her experience |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Algorithm for phenprocoumon | Other | Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according algorithm A published in (Good AC, Henz S. A clinical algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5.) |
| Measure | Description | Time Frame |
|---|---|---|
| rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period | after 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| the time-course of the INR-values, the rate of excessive INR-values, defined as INR >3.5 within 10 days, the rate of minor and major bleeding complications, the length of stay, and death within 30 days | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Henz, MD MPH | Cantonal Hospital of St. Gallen | Principal Investigator |
| Wolfgang Korte, MD | IKCH - Laboratory St. Gallen Switzerland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cantonal Hospital St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17350082 | Background | Good AC, Henz S. A clinical algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5. doi: 10.1016/j.thromres.2007.01.013. Epub 2007 Mar 12. No abstract available. | |
| 23299853 | Derived | Caduff Good A, Nobel D, Krahenbuhl S, Geisen C, Henz S. Randomised trial of a clinical dosing algorithm to start anticoagulation with phenprocoumon. Swiss Med Wkly. 2013 Jan 8;143:w13709. doi: 10.4414/smw.2013.13709. eCollection 2013. |
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| algorithm for phenprocoumon | Other | Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according algorithm B published in (Good AC, Henz S. A clinical algorithm to predict the loading dose of phenprocoumon. Thromb Res. 2007;120(6):921-5.) |
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| Phenprocoumon | Drug | Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according to the discretion of the treating physician |
|
|
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000465 | Algorithms |
| D010644 | Phenprocoumon |
| ID | Term |
|---|---|
| D055641 | Mathematical Concepts |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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