Heart valvular disease
Conditions
Interventions
Group 1:No treatment
Group 2:suspended warfarin therapy, and intravenous dose of 2.5 mg phytonadione
Group 3:suspended warfarin therapy, and intramuscular dose of 2.5 mg phytonadione
Group 4:suspended warfarin therapy, and oral dose of 2.5 mg phytonadione,
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients enrolled in this study were those with warfarin anticoagulant therapy and long-term INR monitoring were used after mechanical valve replacement and INR value was 4.5-10.0, and who were free of any active bleeding or only slight bleeding, were over 18 years old, and who provided written informed consent.
Exclusion criteria
Exclusion criteria: INR determined more than 12 h before screening; predicted life expectancy less than 10 days; indication for the immediate normalisation of their INR; severe liver disease (Decompensated cirrhosis child-pugh grade B, grade C, hepatic encephalopathy, hepatorenal syndrome, hepatic coagulation disease, etc); major bleeding within the previous month; known allergy to vitamin K; known bleeding diathesis or thrombolytic treatment within 48 h of screening; inability to take oral medications; massive bleeding or thromboembolism within one month; platelet count of less than 50 x 10^9/L; and geographic inaccessibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| INR;gene;plasma concentration of phytonadione;Coagulation factor II, IIV, IX, X; | — |
Countries
China
Contacts
Public ContactDong Li
West China Hospital of Sichuan University
Outcome results
None listed