Study to Find Out the Appropriate Initial Dose of the Anticoagulant Drug Phenprocoumon
|ClinicalTrials.gov Identifier: NCT00586287|
Recruitment Status : Completed
First Posted : January 4, 2008
Last Update Posted : April 2, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Embolism Atrial Fibrillation Hip Replacement Postoperative Knee Replacement Postoperative||Other: Algorithm for phenprocoumon Other: algorithm for phenprocoumon Drug: Phenprocoumon||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||302 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Trial of a Clinical Algorithm to Predict the Loading Dose of Phenprocoumon|
|Study Start Date :||January 2007|
|Primary Completion Date :||December 2011|
|Study Completion Date :||December 2011|
Algorithm which uses serum albumin and weight to determine the loading dose of phenprocoumon within the first 5 days
Other: Algorithm for 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.)
Other Name: Marcoumar
Algorithm which uses serum age and weight to determine the loading dose of phenprocoumon within the first 5 days
Other: algorithm for phenprocoumon
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.)
Other Name: Marcoumar
Active Comparator: C
The physician chooses the loading dose of phenprocoumon according to his/her experience
Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according to the discretion of the treating physician
Other Name: 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586287
|Cantonal Hospital St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Principal Investigator:||Samuel Henz, MD MPH||Cantonal Hospital St. Gallen, Switzerland|
|Study Director:||Wolfgang Korte, MD||IKCH - Laboratory St. Gallen Switzerland|