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Prospective Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00634907
First received: February 6, 2008
Last updated: September 25, 2008
Last verified: September 2008

February 6, 2008
September 25, 2008
October 2006
April 2008   (final data collection date for primary outcome measure)
Reduction in the number of adverse events associated with warfarin anticoagulation following total hip and total knee replacement [ Time Frame: Time of warfarin initiation to 3 months after completion of warfarin therapy ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00634907 on ClinicalTrials.gov Archive Site
Improved anticoagulation management in patients on warfarin following total hip and total knee replacement. [ Time Frame: Initiation of warfarin therapy to completion of warfarin therapy ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prospective Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)
Prospective CYP2C9 And VKORC1 Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)For Anticoagulation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Venous Thromboembolism
  • Major Bleeding
  • Genetic: Pharmacogenetic-based warfarin dosing

    Prior to elective joint replacement surgery a blood sample is collected for genetic information(genotyping)which will be used for calculating warfarin doses for patients randomized to the cytochrome arm. Outcomes in terms of efficacy, safety, and management of warfarin will be compared between this group and the group in which warfarin doses are determined per usual care.

    NOTE: Standard of care for elective knee and hip replacement at our institution is to receive post-operative warfarin thromboprophylaxis. Administration of warfarin is not specific to this study, nor is the duration of prophylaxis, however, warfarin dosing will be influenced by the study arm as noted above.

  • Other: Usual care warfarin dosing

    For patients in arm 2, the control group, warfarin dosing is per usual care. Outcomes in terms of safety, efficacy, and warfarin management will be compared to that of patients in the other arm, who receive warfarin dosing based on genotyping.

    NOTE: Standard of care for elective knee and hip replacement at our institution is to receive post-operative warfarin thromboprophylaxis. Administration of warfarin is not specific to this study, nor is the duration of prophylaxis, however, warfarin dosing will be influenced by the study arm as noted above.

  • Experimental: 1

    Pharmacogenetic-based warfarin dosing: Warfarin dosing based on formula that incorporates genetic testing results.

    NOTE: Standard of care for elective knee and hip replacement at our institution is to receive post-operative warfarin thromboprophylaxis. Administration of warfarin is not specific to this study, nor is the duration of prophylaxis, however, warfarin dosing will be influenced by the study arm, as noted above.

    Intervention: Genetic: Pharmacogenetic-based warfarin dosing
  • Active Comparator: 2

    Control or "usual care" warfarin dosing

    NOTE: Standard of care for elective knee and hip replacement at our institution is to receive post-operative warfarin thromboprophylaxis. Administration of warfarin is not specific to this study, nor is the duration of prophylaxis, however, warfarin dosing will be influenced by the study arm, as noted above.

    Intervention: Other: Usual care warfarin dosing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
263
August 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00634907
00019469
Yes
Gwen McMillin, PhD, Medical Director Toxicology and Trace Minerals, Department of Pathology, ARUP Laboratories
University of Utah
Not Provided
Principal Investigator: Gwen McMillin, PhD ARUP Laboratories
University of Utah
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP