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

NCT00586287 | Completed Phase 4

• 2 other identifiers: EKSG 06/022/1BSwissmedic 2006 DR 4 2 7 9
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism; Atrial Fibrillation; Hip Replacement Postoperative; Knee Replacement Postoperative

Keywords

Phenprocoumon; Dosing algorithm; loading dose

Outcome Measures

Primary Outcomes (1)

• rate of patients with therapeutic INR levels on day six without anticoagulation-related complications during the loading period

  after 30 days

Secondary Outcomes (1)

• 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

Study Arms (3)

A

EXPERIMENTAL

Algorithm which uses serum albumin and weight to determine the loading dose of phenprocoumon within the first 5 days

Other: Algorithm for phenprocoumon

B

EXPERIMENTAL

Algorithm which uses serum age and weight to determine the loading dose of phenprocoumon within the first 5 days

Other: algorithm for phenprocoumon

C

ACTIVE COMPARATOR

The physician chooses the loading dose of phenprocoumon according to his/her experience

Drug: Phenprocoumon

Interventions

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.)

Also known as: Marcoumar

A

Phenprocoumon DRUG

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

C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

Study Sites (1)

Cantonal Hospital St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 17350082 BACKGROUND

• 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.

  PMID: 23299853 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism; Atrial Fibrillation

Interventions

Algorithms; Phenprocoumon

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mathematical Concepts; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Samuel Henz, MD MPH

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

• Wolfgang Korte, MD

  IKCH - Laboratory St. Gallen Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Samuel Henz MD MPH

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 4, 2008
• Study Start: January 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 2, 2012

Record last verified: 2012-03

Locations

CH (1)