Post-Marketing Requirement Study to Evaluate the Safety and Efficacy of Octaplas™ in Patients With Thrombotic Thrombocytopenic Purpura With Special Emphasis on Monitoring the Occurrence of Thromboembolic Events
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Octapharma
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- The incidence of TEEs in patients receiving octaplas™ will be compared with the incidence rate in patients receiving plasma issued according to institutional standard of care.
研究概览
简要总结
To assess and evaluate the safety of octaplas™ in comparison to standard plasma product (e.g., fresh frozen plasma (FFP) and other approved plasma products used within 24 hours of thawing) used in the treatment of TTP, in patients undergoing Therapeutic Plasma Exchange, with a special emphasis on the occurrence of thromboembolic events (TEEs).
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
- •Patient is a male or female at least 18 years of age or older.
- •Patient has a diagnosis of TTP or suspicion of TTP that is planned on being treated with TPE within 3 days of study entry.
- •Patient has thrombocytopenia (platelets < 100 x 10P9P/L).
- •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procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
排除标准
- •Patient has a history of severe hypersensitivity reaction to plasma-derived products or to FFP.
- •Patient has an already known IgA deficiency with documented antibodies against IgA.
- •Patient is currently participating in an interventional clinical study or has participated during the past 1 month prior to study inclusion.
- •Patient has severe deficiencies of Protein S.
- •Patient received more than 1 treatment of plasma exchange or plasma infusion for current episode of TTP prior to randomization.
- •Patient is currently taking ACE-inhibitors; in case patient is under ACE-inhibitor treatment a wash-out period of at least 24 hours has to elapse prior the first plasma infusion.
研究组 & 干预措施
Octaplas
Patients receiving Octaplas for the treatment of Thrombotic Thrombocytopenic Purpura (TTP) undergoing therapeutic plasma exchange (TPE) procedures
干预措施: Octaplas (Biological)
standard plasma products
Patients receiving standard plasma products (e.g., FFP, etc) for the treatment of Thrombotic Thrombocytopenic Purpura (TTP) undergoing therapeutic plasma exchange (TPE) procedures
干预措施: Standard Plasma (Drug)
结局指标
主要结局
The incidence of TEEs in patients receiving octaplas™ will be compared with the incidence rate in patients receiving plasma issued according to institutional standard of care.
时间窗: Up to 28 days followed by a 24 hour follow-up
次要结局
- Incidence of Citrate reactions during TPE based on clinical judgment of physician.(Up to 28 days followed by a 24 hour follow-up)
- Incidence of Plasma-associated adverse reactions including Transfusion-Associated Circulatory Overload (TACO),(Up to 28 days followed by a 24 hour follow-up)
- Incidence of Transfusion-Related Acute Lung Injury (TRALI)(Up to 28 days followed by a 24 hour follow-up)
- Incidence of febrile reactions(Up to 28 days followed by a 24 hour follow-up)
- Measurement of Safety laboratory parameters - International Normalized Ratio (INR)(Up to 28 days followed by a 24 hour follow-up)
- Measurement of Prothrombin Time (PT)/Partial Thromboplastin Time (PTT).(Up to 28 days followed by a 24 hour follow-up)
- Determination of overall clinical response (rating scale that takes into account platelet count, LDH levels, creatinine and neurological status).(Up to 28 days followed by a 24 hour follow-up)
- measurement of Platelet count(Up to 28 days followed by a 24 hour follow-up)
- measurement of hemoglobin(Up to 28 days followed by a 24 hour follow-up)
- measurement of hematocrit(Up to 28 days followed by a 24 hour follow-up)
- measurement of LDH.(Up to 28 days followed by a 24 hour follow-up)