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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634907
• Other study ID #: 00019469
• Status: Completed
• Phase: N/A
• First received: February 6, 2008
• Last updated: September 25, 2008
• Start date: October 2006
• Est. completion date: August 2008

Study information

• Verified date: September 2008
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: August 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Major Bleeding
• Thromboembolism
• Venous Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah Health Care	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the number of adverse events associated with warfarin anticoagulation following total hip and total knee replacement		Time of warfarin initiation to 3 months after completion of warfarin therapy	Yes
Secondary	Improved anticoagulation management in patients on warfarin following total hip and total knee replacement.		Initiation of warfarin therapy to completion of warfarin therapy	Yes