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

March 29, 2012 updated by: Samuel Henz, Cantonal Hospital of St. Gallen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • St. Gallen, Switzerland, CH-9007
        • Cantonal Hospital St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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 Names:
  • Marcoumar
Experimental: B
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 Names:
  • Marcoumar
Active Comparator: C
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 to the discretion of the treating physician
Other Names:
  • Marcoumar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period
Time Frame: after 30 days
after 30 days

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital of St. Gallen

Investigators

  • Principal Investigator: Samuel Henz, MD MPH, Cantonal Hospital St. Gallen, Switzerland
  • Study Director: Wolfgang Korte, MD, IKCH - Laboratory St. Gallen Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 4, 2008

Study Record Updates

Last Update Posted (Estimate)

April 2, 2012

Last Update Submitted That Met QC Criteria

March 29, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKSG 06/022/1B
  • Swissmedic 2006 DR 4 2 7 9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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