NL-OMON42527招募中2 期
Randomized double blind placebo-controlled phase II study on the effects of EA-230 on the innate immune response following on-pump cardiac surgery - Immunomodulation of EA-230 following on-pump CABG
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients scheduled for elective on-pump CABG surgery, with or without valve replacement;2. Written informed consent to participate in this trial prior to any study-mandated procedure.;3. Patients aged >18 years, both male and female.;4. Patients have to agree to use a reliable way of contraception with their partners from study entry until 3 months after study drug administration.
排除标准
- •1. Immune compromised;• Solid organ transplantation;• Known HIV;• Pregnancy;• Systemic use of immunosuppressive drugs;2. Non-elective/Emergency surgery;3. Hematological disorders;• Known disorders from myeloid and/or lymphoid origin;• Leucopenia (leucocyte count < 4x10^9/L);4. Use of iohexol contrast <48 hours before start of the first study procedure ;5. Known hypersensitivity to any excipients of the drug formulations used;6. Treatment with investigational drugs or participation in any other intervention clinical trial within 30 days prior to study drug administration;7. Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) ;8. Known or suspected of not being able to comply with the trial protocol.
研究者
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