Point-of-Care Testing (POCT) for Guided Precision Anticoagulation With Warfarin: A Multicenter, Non-concurrent Controlled Study

Launched by RENJI HOSPITAL · Oct 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people who need blood-thinning medication called warfarin. The researchers want to see if using Point-of-Care Testing (POCT)—a quick test done right at the doctor’s office—can help doctors give the right dose of warfarin more effectively compared to another testing method called pyrosequencing. They will look at important factors like how fast patients reach the target level of anticoagulation (blood thinning), how often the dose needs to be adjusted, and how many people experience complications like blood clots or bleeding.

To participate in this trial, you would need to be at least 18 years old, and currently, be hospitalized in a cardiology or cardiovascular surgery department while starting warfarin for the first time. You would also need to agree to be part of the study and sign a consent form. However, there are certain health conditions that could exclude you, such as severe bleeding issues, serious liver or kidney problems, or being pregnant. If you qualify and choose to join, you can expect close monitoring and support throughout the study to help improve the way warfarin is managed for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years, gender unrestricted;
• • Inpatients in the cardiology department and cardiovascular surgery department who are using warfarin for the first time and require continuous treatment for at least 3 months;
• • The patient or legal guardian agrees to the research plan and signs an informed consent form;
• Exclusion Criteria:
• • Patients with contraindications to anticoagulant therapy or those who are scheduled for surgery in the near future;
• • Known genotypes CYP2C9 or VKORC1;
• • Patients scheduled to undergo interventional procedures (such as radiofrequency ablation, cardiac defibrillation) in the near future;
• • Patients with hematological disorders, bleeding disorders, or a tendency to bleed;
• • Patients with severe liver and kidney dysfunction (CrCl \< 15ml/min);
• • Patients with concurrent tumors, severe immune system diseases, or other terminal diseases;
• • Patients with severe heart failure (NYHA Class IV) or severe anemia (hemoglobin \< 60g/L);
• • Pregnant and lactating women;
• • Uncontrolled hypertension (systolic blood pressure \> 180mmHg or diastolic blood pressure \> 120mmHg).