ior ®EPOCIM as a cardioprotective agent in the surgery of rheumatic valvular disease.
- Conditions
- Rheumatic valvular disease
- Registration Number
- RPCEC00000165
- Lead Sponsor
- Center of Molecular Immunology (CIM), Havana
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
1. Patients who require replacement or surgical valve plasty by insufficiency or mitral or aortic stenosis caused by rheumatic fever.
2. Patients with age = 18 years and = 65 years.
3. Patients who have signed the informed consent model.
4. Patients with figures of hemoglobin = 13 g/dL.
1. Patients with uncontrolled arterial hypertension.
2. Patients with insulin-dependent diabetes mellitus.
3. Patients with a known risk or a history of venous or arterial thromboembolic disease.
4. Patients with a known history of renal failure.
5. History of cerebrovascular disease.
6. Oncological diseases.
7. Patients with known hypersensitivity to products derived from upper cells or human albumin.
8. Pregnancy or breastfeeding.
9. Need to replace 2 or more valves or other types of cardiovascular surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postsurgical myocardial damage (cardiac biomarker (troponin T) in ng/mL). Measurement time: 48 hours previous to the intervention, 1st and 2nd postoperative day every 12 hours. Daily in Day 3, 5, and 7 of the postoperative.
- Secondary Outcome Measures
Name Time Method