Study to Find Out the Appropriate Initial Dose of the Anticoagulant Drug Phenprocoumon

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samuel Henz, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00586287
First received: December 20, 2007
Last updated: March 29, 2012
Last verified: March 2012

December 20, 2007
March 29, 2012
January 2007
December 2011   (final data collection date for primary outcome measure)
rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period [ Time Frame: after 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00586287 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Find Out the Appropriate Initial Dose of the Anticoagulant Drug Phenprocoumon
Prospective Randomized Trial of a Clinical Algorithm to Predict the Loading Dose of Phenprocoumon

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pulmonary Embolism
  • Atrial Fibrillation
  • Hip Replacement Postoperative
  • Knee Replacement Postoperative
  • 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
  • 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
  • Drug: Phenprocoumon
    Dosing of phenprocoumon for days 1 to 3, measuring INR and adjust dose according to the discretion of the treating physician
    Other Name: Marcoumar
  • Experimental: A
    Algorithm which uses serum albumin and weight to determine the loading dose of phenprocoumon within the first 5 days
    Intervention: Other: Algorithm for phenprocoumon
  • Experimental: B
    Algorithm which uses serum age and weight to determine the loading dose of phenprocoumon within the first 5 days
    Intervention: Other: algorithm for phenprocoumon
  • Active Comparator: C
    The physician chooses the loading dose of phenprocoumon according to his/her experience
    Intervention: Drug: Phenprocoumon

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
302
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Consecutive inpatients of the internal medicine and the orthopedic surgery department of the Cantonal Hospital of St. Gallen needing new onset oral anticoagulation

Exclusion Criteria:

  • Patients with prior oral anticoagulation with coumarines within less than 6 weeks,
  • patents, who received vitamin-K supplements within less than one week before the onset of oral anticoagulation,
  • patients with liver cirrhosis other than Child A,
  • pregnant women (pregnancy has to be excluded in women of childbearing age),
  • patients younger than 18 years, and
  • patients unwilling or unable to give informed consent
  • patients with (clinically diagnosed) dementia and
  • persons with insufficient German, French, Italian or English language skills)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00586287
EKSG 06/022/1B, Swissmedic 2006 DR 4 2 7 9
No
Samuel Henz, Cantonal Hospital of St. Gallen
Cantonal Hospital of St. Gallen
Not Provided
Principal Investigator: Samuel Henz, MD MPH Cantonal Hospital St. Gallen Switzerland
Study Director: Wolfgang Korte, MD IKCH - Laboratory St. Gallen Switzerland
Cantonal Hospital of St. Gallen
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP