Prospective Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)
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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.
| Condition | Intervention |
|---|---|
|
Venous Thromboembolism Major Bleeding |
Genetic: Pharmacogenetic-based warfarin dosing Other: Usual care warfarin dosing |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective CYP2C9 And VKORC1 Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)For Anticoagulation |
- 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 ]
- 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 ]
| Enrollment: | 263 |
| Study Start Date: | October 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
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. |
|
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. |
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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Utah | |
| University of Utah Health Care | |
| Salt Lake City, Utah, United States, 84132 | |
| Principal Investigator: | Gwen McMillin, PhD | ARUP Laboratories |
More Information
No publications provided
| Responsible Party: | Gwen McMillin, PhD, Medical Director Toxicology and Trace Minerals, Department of Pathology, ARUP Laboratories |
| ClinicalTrials.gov Identifier: | NCT00634907 History of Changes |
| Other Study ID Numbers: | 00019469 |
| Study First Received: | February 6, 2008 |
| Last Updated: | September 25, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Utah:
|
Genotyping Warfarin dosing arthroplasty |
Additional relevant MeSH terms:
|
Hemorrhage Thromboembolism Venous Thromboembolism Venous Thrombosis Pathologic Processes Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Thrombosis Warfarin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013