NCT00611845No Longer Available不适用
Aprotinin US Special Access Protocol: An Open Label, Non-Comparative Treatment Protocol for the Use of Aprotinin in Patients Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass Who Are at Increased Risk of Blood Loss and Transfusion
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- Bayer
研究概览
简要总结
This is a special access protocol that will allow physicians access to aprotinin during the temporary marketing suspension. The program will provide aprotinin for treatment of surgical patients undergoing coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass (CPB) who are at increased risk of bleeding and transfusion when, in the opinion of the treating physician, the patients require it, there is no acceptable alternative therapy, and when there is a clearly favorable benefit-risk for the drug in that individual patient.
研究设计
- 研究类型
- Expanded Access
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
- •Patients 18 years of age and older
- •Patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion. These patients may include the following:
- •Patients receiving preoperative antithrombotic drugs (e.g., clopidogrel, aspirin),
- •Patients undergoing repeat CABG or complex CABG procedures,
- •Patients undergoing urgent or emergent CABG procedures,
- •Patients who refuse to receive allogeneic blood products for religious or other reasons,
- •Patients undergoing primary CABG with advanced age or multiple comorbidities such as preoperative anemia, coagulopathies, diabetes mellitus, and peripheral vascular disease
- •The physician has determined that no acceptable alternative comparable therapy is available for the patient and that there is a clearly favorable benefit-risk for the drug in that individual patient
- •Documented, signed, dated informed consent obtained prior to entry into the study
排除标准
- •Patients with a known or suspected previous aprotinin exposure during the last 12 months. Aprotinin may also be a component of some fibrin sealant products, and the use of these products should be considered when evaluating previous aprotinin exposure
- •Patients with a known or suspected allergy to aprotinin.
研究者
相似试验
No Longer Available
不适用
Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without CataplexyNarcolepsy Without CataplexyNarcolepsy With CataplexyNCT03433131Harmony Biosciences, LLC
No Longer Available
不适用
Abrocitinib Expanded Access Protocol in Adolescents and Adults With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT04564755Pfizer
No Longer Available
不适用
Individual Patient Expanded Access for AB-PA01, an Investigational Anti-Pseudomonas Aeruginosa Bacteriophage TherapeuticNCT03395743Armata Pharmaceuticals, Inc.
Unknown
不适用
Expanded Access Protocol for Patients With Eosinophilic EsophagitisEosinophilic EsophagitisNCT05095116Ellodi Pharmaceuticals, LP
No Longer Available
不适用
Individual Patient Expanded Access for AB-SA01, an Investigational Anti-Staphylococcus Aureus Bacteriophage TherapeuticNCT03395769Armata Pharmaceuticals, Inc.