Expired Study
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Salt Lake City, Utah 84132


Purpose:

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.


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.


Study is Available At:


Original ID:

00019469


NCT ID:

NCT00634907


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Prospective CYP2C9 And VKORC1 Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)For Anticoagulation


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Utah


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

263


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gwen McMillin, PhD
Principal Investigator
ARUP Laboratories

Study Dates

Start Date:October 2006
Completion Date:August 2008
Completion Type:Actual
Primary Completion Date:April 2008
Primary Completion Type:Actual
Verification Date:September 2008
Last Changed Date:September 25, 2008
First Received Date:February 6, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Outcome Type: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
Safety Issues:True

Study Interventions

Intervention Type:Genetic
Name:Pharmacogenetic-based warfarin dosing
Description: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 throm
Arm Name:1
Intervention Type:Other
Name:Usual care warfarin dosing
Description: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 dos
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description: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.
Study Arm Type:Experimental
Arm Name:1
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Utah

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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