Prospective Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)
Information source: University of Utah
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Venous Thromboembolism; Major Bleeding
Intervention: Pharmacogenetic-based warfarin dosing (Genetic); Usual care warfarin dosing (Other)
Phase: N/A
Status: Recruiting
Sponsored by: University of Utah Official(s) and/or principal investigator(s):
Gwen McMillin, PhD, Principal Investigator, Affiliation: ARUP Laboratories
Overall contact:
Roberta Melis, PhD, Phone: 801-583-2787, Ext: 3212, Email: roberta.melis@aruplab.com
Summary
Several human genes affect how medications are metabolized by the body. It is believed that
knowledge of variations of these genes can help health care providers better manage an
anticoagulation medicine called warfarin (Coumadin®)and as a result decrease patient problems
with bleeding or the development of blood clots. This study is designed to evaluate if
genetic testing can improve warfarin initiation better than usual care.
Clinical Details
Official title: Prospective CYP2C9 And VKORC1 Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)For Anticoagulation
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Reduction in the number of adverse events associated with warfarin anticoagulation following total hip and total knee replacement
Secondary outcome: Improved anticoagulation management in patients on warfarin following total hip and total knee replacement.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Participants will be otherwise healthy adults (≥ 18 years of age) who are planning
total hip or knee replacement or revision surgery at the University of Utah Hospital,
and schedule a pre-operative office visit at the University of Utah Orthopaedic
Center.
Exclusion Criteria:
- Blood transfusion in previous two weeks
- Participant is already taking warfarin
- Pre-operative INR > 4. 0
- Pre-operative bilirubin > 2. 4 mg/dL
- Current active cancer diagnosis with ongoing treatment
- Concomitant medications known to exert a major interaction with warfarin such as
septra, metronidazole, tramadol, amiodarone, ciprofloxacin, or cimetidine.
Locations and Contacts
Roberta Melis, PhD, Phone: 801-583-2787, Ext: 3212, Email: roberta.melis@aruplab.com
University of Utah Health Care, Salt Lake City, Utah 84132, United States; Recruiting
Pam Proctor, Email: pam.proctor@hsc.utah.edu
Gwen McMillin, PhD, Principal Investigator
Robert C Pendleton, MD, Sub-Investigator
Elaine Lyon, PhD, Sub-Investigator
Christopher L Peters, MD, Sub-Investigator
Amit Phansalkar, Sub-Investigator
Additional Information
Starting date: October 2006
Ending date: June 2008
Last updated: March 6, 2008
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