A Phase 4 interventional study of Algorithm for phenprocoumon and algorithm for phenprocoumon in Pulmonary Embolism, Atrial Fibrillation and Hip Replacement Postoperative, sponsored by Cantonal Hospital of St. Gallen. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-02.
Sponsored by Cantonal Hospital of St. Gallen · Phase 4, Interventional, and Treatment
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).
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 302 is above the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Cantonal Hospital of St. Gallen is the lead sponsor of 79 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Algorithm which uses serum albumin and weight to determine the loading dose of phenprocoumon within the first 5 days
Other: Algorithm for phenprocoumon
Algorithm which uses serum age and weight to determine the loading dose of phenprocoumon within the first 5 days
Other: algorithm for phenprocoumon
The physician chooses the loading dose of phenprocoumon according to his/her experience
Drug: Phenprocoumon
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.)
Also known as: Marcoumar
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.)
Also known as: Marcoumar
Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according to the discretion of the treating physician
Also known as: Marcoumar
rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period
Time frame: after 30 days
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
Time frame: 30 days
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Cantonal Hospital of St. Gallen