ow dose vitamin K to improve therapeutic quality control of oral anticoagulant treatment: a randomised double-blind placebo controlled trial

Completed

• Conditions: Haematological Disorders; Anticoagulant treatment; Thrombosis, emboly, anticoagulant treatment

• Registration Number: ISRCTN14473912
• Lead Sponsor: eiden University Medical Center (LUMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients treated at the Leiden anticoagulation clinic with an indication for long-term oral anticoagulant therapy using the vitamin K antagonist phenprocoumon
2. Age between 18 and 80 years
3. Informed consent

Exclusion Criteria

1. Treatment by a medical specialist for liver failure
2. Haemo or peritoneal dialysis
3. Pregnancy or a planned pregnancy, puerperium
4. Any chronic condition with an expected median survival of less than 6 months
an expected interruption of oral anticoagulant treatment of more than 1 week
5. Self-management of oral anticoagulant therapy
6. Other drugs affecting haemostasis (aspirin, heparin, clopidogrel)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Quality of anticoagulant treatment<br>2. Expressed as time in therapeutic range

Secondary Outcome Measures

Name	Time	Method
1. Number of international normalised ratios (INRs) in therapeutic range<br>2. Bleeding and thromboembolic complications