Status:
COMPLETED
Oral Vitamin K for Warfarin Associated Coagulopathy
Lead Sponsor:
St. Joseph's Healthcare Hamilton
Collaborating Sponsors:
McMaster University
Conditions:
Coagulation
Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Excessive prolongation of the international normalized ratio (INR) occurs frequently in patients taking warfarin; in fact, about one in six INR values is above the desired range. Excessive prolongatio...
Detailed Description
What is the problem to be addressed ? Although warfarin is a highly effective anticoagulant, it causes bleeding. The risk of bleeding in an individual is increased by a number of factors, including ag...
Eligibility Criteria
Inclusion
- Currently receiving warfarin with a target INR of 2.0 to 3.5
- INR value \> 4.49 and drawn within last 24 hrs
Exclusion
- Elective discontinuation of warfarin
- Age \< 18 years
- Life expectancy of less than 10 days
- Indication for the acute normalization of INR i.e. active major bleeding (bleeding into central nervous system, retroperitoneum or other critical area or any bleeding requiring transfusion), need for surgery, major non-orthopedic surgery within the last seven days, invasive diagnostic procedure, head injury or termination of warfarin
- Known Severe liver disease AST or ALT \> 5 x normal, bilirubin \> 50 umol/litre, known coagulopathy due to liver disease
- Recent (\<1 month) history of major bleeding episode i.e. Hemorrhagic stroke, gastrointestinal bleed or other bleed requiring transfusion or admission to hospital
- Known bleeding disorder or thrombolytic therapy within 48 Hrs i.e. Hemophilia, disseminated intravascular coagulation
- Known allergy to vitamin K
- Inability to take oral medications
- Known significant thrombocytopenia i.e. Platelet count of \< 50 x 10 9/litre
- Geographic inaccessibility/inability to have serial INR's performed
- Failure to obtain informed consent
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
690 Patients enrolled
Trial Details
Trial ID
NCT00143715
Start Date
September 1 2004
End Date
January 1 2007
Last Update
July 20 2011
Active Locations (15)
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1
Kaiser Permanente of Colorado Clinical Pharmacy
Westminster, Colorado, United States, 80234
2
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87106
3
Queen Elizabeth II Health Health Sciences
Halifax, Nova Scotia, Canada, B3H 2Y9
4
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2