EUCTR2009-010191-19-NL进行中（未招募）不适用
A randomized, double-blind, placebo-controlled phase IIIa study on bIAP, an anti-inflammatory moiety,in patients undergoing combined aortic valve replacement and coronary artery bypass grafting. - APPIRED II
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or non-pregnant, non-lactating female patients of any race in the ages of >18 years.
- •2. Patients scheduled for combined aortic valve replacement and CABG surgery
- •3. Patients who have given written informed consent prior to participation in the trial and who undertake to
- •comply with the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who are unwilling or unable to be fully evaluated for follow-up.
- •2. Patients who have base AP levels at > 125 IU/L, or levels < 30 IU/L (ammediol, DEA (diethanolamine) units)
- •3. Patients who show pre-operative infections or who are suspected of endocarditis or systemic infection.
- •4. Patients who refuse to accept medically-indicated blood products.
- •5. Patients who have evidence of significant hepatic disease, including history of clinical signs or laboratory values of total bilirubin > 34.2 µmol/L (> 2.0 mg/dL), ALT (>120) or AST (>135) corresponding to > 3X upper limit of normal.
- •6. Patients who received investigational drugs in the 30 days prior to study drug administration, or are currently participating in a study during which the administration of investigational drugs within one month is anticipated.
- •7. Patients who require pre-operative ventilatory support.
- •8. Patients who have renal insufficiency (history of creatinine >177µmol/L or >2.0 mg/dL) or chronic renal failure requiring dialysis.
- •9. Patients who are planned to receive leukocyte-depletion filtration as part of the bypass circuitry.
- •10. Patients with severe neurological deficits.
- •11. Patients who have a recent history of drug or alcohol abuse.
- •12. Patients with a diagnosis of idiopathic thrombocytopenia.
- •13. Patients with a history of cancer who have received chemotherapy or radiation therapy within the past 3 months. Patients receiving only adjuvant hormonal therapy are not excluded.
- •14. Patients who are scheduled to receive stress doses of glucocorticoids (i.e., doses >2 mg/kg/day of methylprednisolone or equivalent) prior to, during or following surgery.
- •15. Patients who are vegetarians or veganists or those patients that may be expected not to be tolerant for bovine proteins.
- •16. Patients who are, in the opinion of the investigator, unsuitable for the study. A well-documented screening log should be present in the clinic.
研究者
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