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临床试验/RPCEC00000165
RPCEC00000165已完成2 期

Evaluation of the effect and safety of recombinant human erythropoietin (ior ®EPOCIM ) as a cardioprotective agent in the surgery of rheumatic valvular disease.

Center of Molecular Immunology (CIM), Havana0 个研究点目标入组 30 人开始时间: 2013年8月26日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

入排标准

年龄范围
18 years 至 65 years(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

研究者

发起方
Center of Molecular Immunology (CIM), Havana

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