NCT01010724已完成3 期
A Randomized, Double-Blind, Placebo Controlled Study of Biap, an Endotoxin Detoxificating Moiety, in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass
Catharina Ziekenhuis Eindhoven1 个研究点 分布在 1 个国家开始时间: 2009年11月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- To determine the efficacy and safety of bIAP as a prophylaxis against endotoxin-mediated complications from cardiopulmonary bypass surgery
研究概览
简要总结
The study drug bIAP, or matching placebo, will be administered as a bolus of 1000 Units bIAP or matching placebo prior to anaesthesia (T = -15 minutes), directly followed by intravenous continuous infusion of about 5.6 units per kg bodyweight/hr at pump rate 4 ml/hr for approximately 36 hrs (total 200 IU/kg/36 hrs) into each of a total of 50 patients scheduled for coronary artery bypass graft surgery (CABG). Risk of surgical complications and mortality due to co-morbid conditions will be collected and the EuroSCORE will be used to screen patients prior to surgery.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-lactating female patients of any race in the ages of >18 years. Women must be of non-childbearing potential.
- •Patients scheduled for coronary artery bypass surgery with CPB.
- •Patients must have a EuroSCORE (Appendix I) of >2 and <
- •Patients who have given written informed consent prior to participation in the trial and who undertake to comply with the protocol.
排除标准
- •Patients who are unwilling or unable to be fully evaluated for follow-up.
- •Patients who undergo CABG for emergency due to complications from percutaneous transluminal coronary angioplasty (PTCA)/ catheterization, unstable angina or ongoing myocardial infarction.
- •Patients who have base alkaline phosphatase levels at > 100 IU/l (70 IU/L as mean concentration) levels, or levels < 30 IUnits/L (ammediol, DEA units)
- •(values base levels in glycine units at pH9.6 and 25 C are respectively >40 and < 12 IU/L).
- •Patients who show pre-operative infections or who are suspected of having endocarditis or systemic infection.
- •Patients who refuse to accept medically-indicated blood products.
- •Patients who have evidence of significant hepatic disease, including history of clinical signs or laboratory values of total bilirubin > 2.0 mg/dL, ALT or AST> 3X upper limit of normal.
- •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.
- •Patients who require pre-operative ventilatory support.
- •Patients who have renal insufficiency (history of creatinine> 2.0 mg/dL) or chronic renal failure requiring dialysis.
- •Patients who are planned to receive leukocyte-depletion filtration as part of the bypass circuitry.
- •Patients with severe neurological deficits (see Appendix I).
- •Patients who have a recent history of substance or alcohol abuse.
- •Patients with a diagnosis of idiopathic thrombocytopenia.
- •Concomitant surgical procedures (i.e., not included in Appendix VI) anticipated to require greater than 2.5 hours time "on-pump" or patients for whom surgery other than coronary artery bypass surgery is planned during the 30-day study period.
- •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. If the cancer has not resolved completely, the patient should not be enrolled without permission of Alloksys.
- •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 the operation.
- •Patients who are vegetarians or vegenists or those patients that may be expected not to be tolerant for bovine proteins.
- •Patients who have a BMI (body mass index) < 18 or > 30
- •Patients who are, in the opinion of the Investigator or the Sponsor, unsuitable for the study.
研究组 & 干预措施
bIAP
Experimental
Dosage 200 IU bIAP/kg: 1000 IU prior to anaesthesia administered as a bolus followed by intravenous continuous infusion of 5,6 IU/kg/hr for approximately 36 hours.
干预措施: bIAP (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the efficacy and safety of bIAP as a prophylaxis against endotoxin-mediated complications from cardiopulmonary bypass surgery
次要结局
未报告次要终点
研究者
研究点 (1)
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