N/A
N=263
Prospective Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)
Venous Thromboembolism · Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT00634907 ↗Enrolled (actual)
263
Serious AEs
2.6%
Results posted
Jun 2017
Primary outcome: Primary: The Number of Participants With Adverse Events Associated With Warfarin Anticoagulation Following Total Hip and Total Knee Replacement — 2; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pharmacogenetic-based warfarin dosing (Genetic); Usual care warfarin dosing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gwen McMillin
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Adverse Events Associated With Warfarin Anticoagulation Following Total Hip and Total Knee Replacement |
2; 4 | — |
| SECONDARY Percentage of Determinations in Therapuetic Range (INR 1.8-2.9) |
43.3; 44.9 | — |
| SECONDARY Percentage of Determinations Subtherapeutic (INR<1.8) |
48.0; 47.1 | — |
| SECONDARY Percentage of Determinations Supratherapeutic (INR>2.9) |
8.7; 8.0 | — |
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 was designed to evaluate if genetic testing can improve warfarin initiation better than usual care.
Eligibility Criteria
Inclusion Criteria
- Participants were otherwise healthy adults (≥ 18 years of age) who were planning total hip or knee replacement or revision surgery at the University of Utah Hospital, and scheduled 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.
Data sourced from ClinicalTrials.gov (NCT00634907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.