ior ®EPOCIM as a cardioprotective agent in the surgery of rheumatic valvular disease.

Phase 2

Completed

• Conditions: Rheumatic valvular disease

• Registration Number: RPCEC00000165
• Lead Sponsor: Center of Molecular Immunology (CIM), Havana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-26
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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.

Exclusion Criteria

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