Complications Due to Heart Valve Prosthesis
Conditions
Keywords
Cost-Effectiveness,, Heart valve prosthesis, Warfarin,, Aspirin,, Egypt
Brief summary
The combined Antiplatelet and Anticoagulant treatment decreased thrombus formation and overall mortality. Also the initiation of an efficacious early anticoagulation protocol is important because of its potential impact on the rate of early thromboembolic complications after mechanical valve implantation. An important question that remains to be answered is whether the combination would be cost effective than Warfarin alone, with a reduction in major bleeding. In addition, the knowledge about its cost-effectiveness has not yet been established in Egypt. The aim of this trial based economic evaluation is to conduct a cost-effectiveness analysis for combination of low-dose Aspirin and Warfarin versus Warfarin alone in prosthetic valve patients from the medical provider perspective specially that a misconception is still existed between the physicians in Egypt that the cost of complications is not worthy so our main aim is to test the cost of complications.
Detailed description
The measurements will be assessed: A- Number of patients improved during follow up: 1. Demographic data 2. Diagnosis 3. Laboratory tests (CBC, Prothrombin Time, liver and renal function tests) 4. Echocardiography profile B-Costs: Direct medical costs will be assessed directly from hospital's records and tender lists.
Interventions
Sugar pill manufactured to mimic 75 mg Aspirin
Sponsors
Study design
Eligibility
Inclusion criteria
Patients operated in Ain Shams University Hospitals for aortic and/ or mitral valve replacement.
Exclusion criteria
* Congenital blood disorders, Hemophilia. * Advanced liver disease * Advanced renal disease (dialysis patients) * Aspirin sensitivity * Autoimmune diseases * Biological bioprosthesis valves * Non-compliant & Drop out patient * Pregnant women * Caucasians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Valve Thrombosis | one year |
Secondary
| Measure | Time frame |
|---|---|
| Major Systemic Embolism, | one year |
| Non-fatal intracranial hemorrhage | one year |
| Major extra cranial hemorrhage, | one year |
Countries
Egypt