Heart valve disease
Conditions
Interventions
Intervention group:The mode of doctor's medication adjustment assisted by artificial intelligence model
Control group:Routine doctor's medication adjustment model
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older; 2. Adult patients undergoing their first heart valve surgery, who are treated with warfarin anticoagulation therapy after the surgery.
Exclusion criteria
Exclusion criteria: 1. Known allergy to warfarin or its excipients; 2. Oral intake of novel oral anticoagulants such as dabigatran or rivaroxaban; 3. Severe abnormal baseline coagulation function: baseline INR > 1.5 (not caused by warfarin); platelet count 3 times the upper limit of normal; serum albumin =100 mL in 24 hours), massive hematemesis/gastrointestinal bleeding (>=500 mL in 24 hours, or accompanied by hypotension or shock); massive hematuria, retroperitoneal bleeding, intra-articular bleeding, or clinically significant bleeding in other major organs (such as liver, lungs, adrenal glands) accompanied by organ dysfunction. Active peptic ulcer or intracranial hemorrhage is also included; 7. Recent history of thromboembolism: any arterial or venous thromboembolic event within 3 months prior to enrollment, such as stroke (ischemic), transient ischemic attack (TIA), systemic arterial embolism (e.g., limb arterial embolism, mesenteric arterial embolism, myocardial infarction due to coronary arterial embolism), deep vein thrombosis (DVT), pulmonary embolism (PE), prosthetic valve thrombosis. Patients with antiphospholipid syndrome are included; 8. Uncontrolled severe hypertension (e.g., systolic BP > 180 mmHg or diastolic BP > 110 mmHg); 9. Pregnant women or women of childbearing potential planning pregnancy during the study period (not using effective contraception); 10. Severe cognitive impairment or psychiatric disorders; 11. Refusal to sign informed consent or unwillingness to comply with the study protocol; Exclusion after surgery: 12. Requirement for reoperation during post-operative hospitalization; 13. Severe non-anticoagulation-related complications during post-operative hospitalization, such as heart failure, renal failure, liver failure, severe infection leading to extremely unstable INR, making routine anticoagulation management difficult; 14. Poor compliance with anticoagulation management, such as not following prescribed medications during hospitalization or self-discontinuation of medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| INR compliance rate at discharge; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of days with INR reaching the target;Variability of INR;Time for INR to reach target; | — |
Countries
China
Contacts
Public ContactBenqing Zhang
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed