Post-Marketing Requirement Study to Evaluate the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation With Special Emphasis on Hyperfibrinolysis.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Octapharma
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- To assess the incidence of hyperfibinolysis in patients undergoing OLT receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma (FFP) and other FDA and American Association of Blood Banks (AABB) approved plasma products).
研究概览
简要总结
Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (OLT). The primary objective is to assess the incidence of hyperfibrinolysis in patients undergoing (OLT) receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma and other FDA and AABB approved plasma products).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 female age ≥18 years
- •Patient is scheduled to undego orthotopic liver transplantation (OLT)
- •Patient has a natural MAYO End-Stage Liver Disease (MELD) score of 15-40
- •Patient is willing to give voluntary written informed consent before any study- related procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudicing future medical care
排除标准
- •Patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product
- •Patient is known to be IgA deficient with documented antibodies against IgA
- •Patient is a planned recipient for a living donor OLT
- •Patient has a severe deficiency of Protein S
- •Patient is currently participating in an interventional clinical study or has participated in one within 30 days of the date of their OLT
结局指标
主要结局
To assess the incidence of hyperfibinolysis in patients undergoing OLT receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma (FFP) and other FDA and American Association of Blood Banks (AABB) approved plasma products).
时间窗: 3 days (perioperative period plus post-operative follow-up)
The incidence of 'clinically relevant hyperfibrinolytic events' in patients receiving octaplas™ will be compared with the incidence rate in patients receiving plasma. For this trial a 'clinically relevant hyperfibrinolytic event' is defined as a decrease of at least 7.5% in the maximum amplitude (MA) as measured by the thromboelastography (TEG) or rotational thromboelastography (ROTEM) within 30 minutes after MA is achieved and the event is associated with bleeding requiring intervention.
次要结局
- The safety of octaplas™ in comparison to plasma will be assessed by monitoring the occurrence of adverse drug reactions (i.e., transfusion reactions).(3 days (perioperative period plus post-operative follow-up))